Last week’s round-up; 22 – 26 June 2020

Mutual Recognition of European/US GMP Inspections

Earlier this month, the European Commission, EMA and the FDA held their 2020 bilateral regulatory dialogue meeting. Various topics were discussed including the mutual recognition of GMP inspections. In July 2019, the authorities fully implemented the MRA for certain human medicines, and in this month’s meeting the next milestones in this regard were tackled. These milestones include the expansion of the MRA to veterinary medicines and the inclusion of vaccines and plasma-derived products by July 2022 is under consideration.

https://bit.ly/RealCMC-31pCjZ8

EC: European Reference Networks (ERN) ecosystem to horizon 2030

In 2 virtual meetings organized on 17 and 18 June, the Coordinators and the Board of Member States shared information on initiatives put in place during the pandemic to support patients affected by rare diseases and to draw lessons for a potential second wave. They discussed the questions related to the on-going enlargement process of the ERNs through the recent inclusion of Affiliated partners and the forthcoming new members in 2021. They also spoke to the implications in terms of financing, use of the virtual consultation platform CPMS and integration of the ERNs within national systems. The discussions on the current system, then kick-started a brainstorming concerning a more long term vision of the whole ERN ecosystem by horizon 2030, that will continue for discussion in future meetings.

The entire press release can be found here:  https://lnkd.in/dsUUHTg

EMA nominates Emer Cooke as new EMA Executive Director

At an extraordinary virtual session on 25 June, the Board of the EMA selected Emer Cooke from a shortlist of candidates created by the European Commission.Ms Cooke will now be invited to give a statement to the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) on 13 July 2020. The appointment of the new Executive Director will be made after that meeting. Emer Cooke, an Irish national, is currently the Director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva.

Further details of the press release can be found here: https://lnkd.in/d3FzZhk

EMA Press Release:  Data requirements for phase 3 COVID-19 trials

Convergence on key aspects of phase 3 CT designs will help developers to generate robust evidence on potential COVID-19 vaccines and to consistently meet the needs of global regulators. This should expedite and streamline development and authorisation of vaccines against COVID-19. On 22 June in a workshop organised by EMA and FDA under the umbrella of ICMRA, global regulators focused on non-clinical and clinical data from early phase studies that are needed before proceeding with advanced (phase 3) trials, further details can be found here: https://lnkd.in/dSxNeJ7

Nitrosamines and other unexpected impurities: lessons learnt

The European Commission, the EMA, national competent authorities in the EEA and the EDQM have issued recommendations that draw on lessons learnt from the presence of nitrosamines in sartan medicines, which are widely used to control blood pressure. With these recommendations, European regulators aim to clarify the roles and responsibilities of pharmaceutical companies and to amend the guidance on the control of impurities and GMP. The management of detected impurities, communication with patients and healthcare professionals, and international cooperation are also included in the recommendations. The European Network hopes that this guidance will help regulators and companies prevent and mitigate the risks of nitrosamines and other unexpected impurities in the future.

https://bit.ly/RealCMC-2A71p44

FDA, EC and EMA intensify collaboration

The EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Topics discussed in the June meeting include; sharing experience and challenges on development of Covid19 vaccines, co-operation on therapies for ultrarare diseases, real world evidence, GMP mutual recognition agreements, orphan and pediatric medicines.

The full press release can be found here: https://lnkd.in/dmd44NW

Free EMA SAWP protocol assistance for Academia

Free EMA SAWP protocol assistance for Academia Applicants from the academic sector can receive free protocol assistance for developing orphan medicines, as of 19 June 2020.   EMA offers this incentive to further encourage the development of medicines for rare diseases. The fee waiver for academia is available to: public or private highereducation establishments awarding academic degrees; public or private non-profit research organisation whose primary mission is to pursue research; international European interest organisations (as defined in Regulation (EU) No1290/2013).  Firstly, the applicant must be established in the EEA.  Secondly, the applicant must neither be financed nor managed by private for-profit organisations in the pharmaceutical sector, nor have concluded any agreement with any pharmaceutical companies about sponsorship or participation in the research project in question.

Full details of the scheme can be found here: https://www.ema.europa.eu/en/partners-networks/academia

EMA SAWP meeting dates for 2021

EMA has issued dates for the 2021 SAWP meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation requests. Full details can be found under this link: https://lnkd.in/gQyeQkS

EC requests expression of interest in a consultation on voluntary sharing of market launch intentions

The EC has invited stakeholders to comment on a pilot project which will request prospective MAHs to declare their market launch intentions on a voluntary and confidential basis. The pilot aims to raise awareness of the limited roll-out of CP medicines in some EU Member States, and to improve regulators’ understanding of the reasons behind delayed market launch. The focus of the pilot will be on orphan medicines and medicines to treat cancer with the deadline for comments on 22 July 2020.

As link to the EC site can be found here: https://lnkd.in/dTgpa8m

Ph. Eur. Revised Raman Spectroscopy Chapter Public Consultation

The Ph. Eur. is seeking feedback on the revised draft chapter 2.2.48 on Raman Spectroscopy. Recent technological developments in Raman spectrometry have prompted several updates as well as the addition of new sections to the chapter: • Update of the section on response-intensity scale. • A new section on spectral resolution using calcium carbonate. • Procedures for the comparison of spectra have been included. The draft chapter is published in Pharmeuropa 32.3 and is open for public consultation between July and September 2020. Users who wish to submit comments but are unable to do so by the end of the consultation period due to COVID-19, are encouraged to contact their National Pharmacopoeia Authority in Ph. Eur. member states or the EDQM Helpdesk. https://bit.ly/RealCMC-2Yrh1Zy

EC proposes relaxing GMO regulations for COVID-19 vaccines

The European Commission (EC) has proposed changes to the EU regulation of genetically modified organisms (GMOs), which would relax the requirements for the development of COVID-19 vaccines. The proposed changes would allow the clinical trials of GMO-containing candidate vaccines and COVID-19 treatments to start within the shortest possible timelines. The EC still plans to include an environmental risk assessment as part of the marketing authorization procedure for any products that fall under the proposed relaxed GMO regulations. These proposed regulations would also allow the distribution of medicinal products containing GMOs under a compassionate use exemption of Regulation (EC) No 726/2004. The EC has also indicated that this proposed regulation is temporary and is applicable only for the duration of the pandemic:  https://bit.ly/RealCMC-3hSN0t0

EMA: Updated procedural advice for orphan medicinal product designation

The EMA updated its procedural advice for orphan medicinal product designations on 15th June 2020. Applicants are now required to provide a description of the mechanism of action of their medicine in lay language in a maximum of 100 words. The text should describe as simply as possible the clinically relevant principle mechanism of action, in relation to the condition applied for. If orphan status is granted the text provided will be included in the public summary of the orphan designation published on the EMA website. The preferred format of the document is word format which should be submitted via IRIS with the other required documents listed in section 3.2 of the procedural advice. https://lnkd.in/gSb22Qe

Brexit:  Joint letter on the need for a Mutual Recognition Agreement (MRA) between the EU and UK

Six organisations from biopharma industry, including EFPIA and EUCOPE, have urged the EU to separate talks about post-Brexit regulatory cooperation from broader political negotiations. The plea is made amid fears the collapse of free trade talks will force a hard split between the UK and EU regulatory regimes. Particularly in current environment they stress it is crucial to ensure as much cooperation as possible with regard to regulatory processes and the import and export of medicines and medical supplies across UK/EU borders, in order to minimise delays in products reaching patients.

The letter in full can be found here:  https://lnkd.in/geJSech 

International Coalition of Medicines Regulatory Authorities (ICMRA) issues statements on vaccines to the public and HCPs

ICMRA has issued statements on vaccine confidence for the general public and on vaccine safety and effectiveness for HCPs. They explain the robust scientific and independent processes that medicines regulators worldwide follow, that ensure only vaccines that conform to the highest standards of safety and effectiveness can reach and remain on the market.

Full details of the statements in 7 languages can be found under this link: https://lnkd.in/d4FRN5c

Last week’s round-up; 15 – 19 June 2020

Ph.Eur. Supplement 10.3

The EDQM has published the contents of the Ph.Eur. Supplement 10.3. The list includes several new texts, such as the new monograph for testing bacterial endotoxins using recombinant factor C (2.6.32), as well as many revised general chapters and monographs. These new and revised texts will be implemented by 1st January 2021. Several corrected texts are also included in the list and these should be implemented by 31st August 2020. The list also includes texts that will be deleted from the Ph.Eur.

The entire list of contents of Supplement 10.3 may be viewed here: https://bit.ly/Realcmc-2BiFQxI 

New EMA Bioequivalence Guidance for Levothyroxine Tablets and Abiraterone Tablets

The EMA has released the following draft product-specific guidelines: • A new bioequivalence guideline for Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg. • An updated bioequivalence guideline for Abiraterone tablets, which includes the addition of the 500 mg strength.

These draft guidelines are open for public consultation until 30th September 2020. https://bit.ly/RealCMC-2UVpfae

EMA, EC and Health Canada Confidentiality Arrangement

EMA, the European Commission and Health Canada signed a confidentiality arrangement in 2007. This was renewed in 2013 and 2020. The most recent changes introduced in 2020 include references to personal data legislation and to ensure the permanent validity of the arrangement.

The full document is available here: https://lnkd.in/gHugfvC

FDA testing methods to detect nitrosamine impurities in Metformin

The FDA has published two analytical methods that regulators and pharmaceutical companies may use to detect nitrosamine impurities in metformin APIs and drug products: • LC-HRMS method: an LC-MS method for the detection of NDMA in metformin drug substance and drug products. • LC-ESI-HRMS method: an LC-HRMS method for the measurement of amounts of eight nitrosamine impurities in metformin drug substance and drug products. Users are required to validate these methods if the resulting data is used to support a quality assessment of the API or drug product or regulatory submissions: https://bit.ly/RealCMC-3ftP7lh 

Global regulators work towards alignment

The International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular meeting on 12 June 2020 to discuss high-level policy and regulatory approaches in response to COVID-19. They agreed that a clear distinction between exploratory clinical trials and confirmatory studies with investigational or repurposed medicines for treatment of COVID-19 is critical for prioritisation. Regulators also shared concerns about the discontinuation of clinical trials globally and the growing number of underpowered studies that might not generate the robust data required for decision-making. Full details of the output from the meeting can be found here https://lnkd.in/dgmFZgQ

EDQM companion list of training materials for vaccines

In order to support vaccine developers during the COVID-19 pandemic, the EDQM has made the Ph.Eur. quality standards for vaccines freely accessible through an online database on the EDQM website. Further to this, the EDQM has now also compiled a companion list of training materials related to vaccines. The document is intended for COVID-19 vaccine developers, including universities and small and medium-sized enterprises, with the intention to fast track their understanding of the Ph. Eur. and to help them to apply the relevant texts. The EDQM’s companion list includes hyperlinks to various presentations that were originally given at an EDQM Training Session on Biologicals held in February 2020 and any content of specific interest for vaccine developers is highlighted.

The list is not exhaustive and will be reviewed and updated as required. https://bit.ly/RealCMC-2BgwAd6

EMA and HMA news:  Mandate of the European Innovation Network

EMA and HMA have issued an update to the document describing the mandate of the European Innovation Network (EU-IN), which seeks to coordinate and integrate views of national agency innovation offices and EMA’s Innovation Task Force for the early identification of promising developments, integration in the EU adaptive pathways, facilitate national designation of small and medium enterprises (SMEs) and to investigate the establishment of harmonised criteria for borderline products.

The full mandate can be found here: https://lnkd.in/dBXHQby

Last week’s round-up; 18 – 22 May 2020

EMA UPDATES – CENTRALISED PROCEDURE

The EMA has released several updates to its pre-authorisation and post-authorisation procedural advice for users of the centralised procedure. Some of the updates include:

 

The EMA now aims to respond to queries within 10 days instead of 5. Other changes as can be seen in the tracked documents linked here: https://lnkd.in/dpW7TF7

ICH PLOTS CLOSER COLLABORATION WITH PIC/S

The International Council for Harmonisation (ICH) Management Committee and Assembly has indicated that it intends to collaborate more closely with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) and that new topics and reflection papers are currently under development.

ICH Management Committee has proposed that the PIC/S would be involved in ICH guideline work relevant to regulatory assessor [MG1] and inspector disciplines, during the public consultation following Step 2b. Additionally as an ICH Observer, the PIC/S may also request to be part of Plenary Working Parties which would allow its involvement prior to Step 1.

A revised draft reflection paper on model-informed drug development and an update on a draft reflection paper on patient-focused drug development are also in the pipeline. The Biotechnology Innovation Organization has also proposed to develop a reflection paper on gene therapy harmonization. https://bit.ly/RealCMC-3eagyQe

PH. EUR. 2.4.35 EXTRACTABLE ELEMENTS IN PLASTIC MATERIALS FOR PHARMACEUTICAL USE

Pharmeuropa has released new supporting information on the new draft Ph. Eur. Chapter 2.4.35 ‘Extractable elements in plastic materials for pharmaceutical use’, which is open for consultation until the end of June 2020. The document proposes that the long‑established individual tests for specific elements are maintained in the Ph. Eur. general chapters on plastic materials, since the quality of plastic materials influences that of the containers manufactured from them.

In future, cross‑reference to this new general chapter will also be made in each existing Ph. Eur. text on plastic materials. The supporting information also indicates that all the existing Ph. Eur. general chapters on plastic materials should be revised to delete the heavy metals test and to perform the tests on target elements according to the new general chapter. https://bit.ly/RealCMC-3bUORJM

MHRA GUIDANCE- EFFECTIVE FIELD SAFETY NOTICES (FSNS) FOR MANUFACTURERS OF MEDICAL DEVICES

“Field Safety Notices (FSNs) are a key part of the medical device vigilance system. Manufacturers are required to inform users about corrective actions involving their device as soon as possible using a Field Safety Notice (FSN). Published on the 20th May by the MHRA to advise manufacturers on how to write clear FSNs to maximise response rates the guidance provides supplementary information to MEDDEV 2.12/1 rev 8 (how to write and distribute effective FSNs) and covers such topics as good traceability, content, effective targeting of FSNs and Field Safety Corrective Action (FSCA) strategy. Manufacturers are advised to read the document via the following link: https://bit.ly/36hrYiH.

2nd DIA – EUCOPE WORKSHOP ON ATMPs INNOVATIVE GENE AND CELL THERAPIES

We’re proud to have our Real expert, Dorothée Fouchier, attending the virtual 2nd Joint DIA-EUCOPE Workshop on ATMPs, Innovative Gene and Cell Therapies, next week alongside our industry peers to discuss the challenges, opportunities and political implications of advanced therapies. If you’re also attending, get in touch! To arrange a meeting visit: https://lnkd.in/dc_SDsr

FEE REDUCTIONS FOR GMP INSPECTIONS

The European Medicines Agency (EMA) has reduced the fee for on-site GMP inspections by 100%. This fee reduction is only applicable in cases where the GMP compliance of a manufacturing site with restricted access due to the COVID-19 pandemic, could not be confirmed via a distant assessment and an on-site inspection is, therefore, required. Fees for Plasma Master Files inspections will also be similarly reduced.

The EMA has also advised that during this initiative, remuneration to national competent authorities (NCA) will not be reduced, if the NCA provides a comprehensive inspection report for the distant assessment and a subsequent independent report for the on-site inspection. Further information is available here: https://bit.ly/RealCMC-2XbhKMr

EMAS INNOVATION TASK FORCE (ITF) NEW BRIEFING MEETING REQUEST FORM

The scope of EMAs ITF covers regulatory, technical and scientific issues arising from innovative medicines development, new technologies and borderline products. The objective of the interactions with the ITF is to facilitate informal exchange of information and guidance during the product development process. Interactions take the form of informal brainstorming discussions are led by experts from the Agency network, working parties and committees. These meetings are free of charge and 1.5 hours long. ITF has just issued a new briefing meeting request form in order to standardise company initial dialogue. The form can be found here: https://lnkd.in/dTK2axt

MHRA INSPECTORATE: HOW TO MANAGE TEMPORARY GDP PROCESS CHANGES AND RISKS THROUGH THE COVID-19 PANDEMIC

The MHRA inspectorate posted ‘How to manage temporary GDP process changes and risks through the COVID-19 pandemic’ on their blog on the 13th May to advise companies on how to manage changes to GDP processes to address exceptional circumstances that have arisen due to Covid-19. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles. Changes may be documented either as single reports or an over-arching one specific to COVID-19. The post has a link to GDP flexibilities introduced by the MHRA to assist with distribution of medicines during COVID-19 pandemic documented in ‘Guidance Exceptional GDP flexibilities for medicines during COVID-19’. The GDP flexibilities introduced cover Supply Chain, Transportation, RP, Facilities & Equipment and Reporting.

Companies applying these flexibilities need to report to Covid19.GMDP@ mhra.gov.uk as outlined in the guidance, however you only need to report once for each flexibility and reports don’t require approval to implement. The post can be accessed via this link: https://bit.ly/2LIjR5g

GETTING YOUR 505(b)(2) PRODUCT APPROVED IN EUROPE

The 505(b)(2) route to marketing authorisation in the United States has become very popular. Companies owning a product registered (or eligible to be registered) via this pathway might also wish to submit their product in Europe. Real Regulatory can help companies navigate the significant complexities involved in choosing an appropriate legal basis for submission, setting regulatory strategy and dealing with scientific advice and marketing authorisation procedures.

Read the linked article for an overview of the intricacies and the ways in which we can assist. https://lnkd.in/dzjU_Jj

NEW VERSION OF MHRA APPLICATION FOR ‘SPECIALS’ LICENCE

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a new version of its ‘Application for new Manufacturer’s “Specials” Licence (MS) (Human Use).

To access the new version of the application form please see the following link: https://bit.ly/RealCMC-2ThytN4

Two Teams, United as One

We have an exciting announcement to make. Over the next few days, you may notice some changes on our website.

We have decided to bring our sister company Real Generics under our Real Regulatory brand.

Real Generics has been in business since 2015 and we have decided to make this change now  to better reflect the services we as a group are providing to all kinds of clients for a wide variety of product types, including generics, hybrids, herbals, biosimilars, new combinations, as well as brand new products that are entirely research-based. This is simply just a change in name, therefore the team, the services we provide and our reason for being remain exactly the same. Be sure to follow them here: https://www.linkedin.com/company/10056748

If you have any feedback for us do let us know via the contact form https://www.realregulatory.com/contact/

Last weeks round-up; 27 April 2020 – 1 May 2020

DO YOU WANT UP TO 90% FEE REDUCTIONS AT EMA?

Do you want to access up to 90% fee reductions at EMA?

No existing legal company entity within EU/EEA?

Do you meet the criteria for SME status?

If YES, then Real Regulatory has the solution. Check out the criteria here https://lnkd.in/dKidU2Z, your company can abridge on the existing Real Regulatory SME status to quickly become eligible for the SME incentives. Contact us to action your application now. https://lnkd.in/daQjxxj

AMENDING THE DETAILS OF AN EU ORPHAN DRUG DESIGNATION SPONSOR

EMA has issued updated instructions on how to amend the name and/or address details of a Sponsor of an Orphan Drug Designation. This does not require a new legal act, provided that the sponsor remains the same person or legal entity. Sponsors need to use EMA’s IRIS platform to submit post-designation activities. EMA will not be able to process any submissions outside of IRIS. A change in the name and/or address can be requested only after a designation has been granted by the European Commission. Full details of the guidance can be found https://lnkd.in/dDuFNXs

MCDG GUIDANCE ON MDR CLINICAL INVESTIGATIONS AND EVALUATIONS

Guidance is now available to assist stakeholders in implementing the MDR Clinical Investigation and Clinical Evaluation requirements. The Medical Device Coordination Working Group (MDCG) developed the following guidance documents which were published on the website of the European Commission (EC) on the 23rd April:

The documents provide much needed clarification on MDR requirements pertaining to clinical data and demonstration of equivalence. The documents can be accessed via the following link https://bit.ly/35hqlkA.

EC: MITIGATING CLINICAL TRIAL DISRUPTION IN EUROPE

The European Commission (EC) has issued guidance to ensure that clinical trials can continue during the COVID-19 pandemic. The aim is to mitigate the disruption of clinical research without compromising on quality and safety. With more than 200 coronavirus clinical trials now registered in the EudraCT database, the guidance offers recommendations for simple and flexible measures. Key recommendations of the guidance cover, distribution of medicines to patients, remote source data verification, and communications with authorities. For the latter, the guidance clarifies the classification and notification of these actions. The measures will be used exclusively during the coronavirus pandemic, and will be revoked once the current health crisis in the EU/EEA has been surpassed. https://lnkd.in/gRc5XkX

MDR POSTPONED BY ONE YEAR

In response to Covid-19 the European Commission (EC) adopted a proposal on the 3rd April to postpone by one year the application of the Medical Devices Regulation (MDR). The European Parliament adopted the proposal on the 17th April, followed quickly by adoption of the Council on 22 April. The EC has announced that the amending Regulation 2020/561 was published in the Official Journal on the 24th April and has entered into force on its date of publication. This means that the date of application of the MDR will become 26 May 2021 instead of 26 May 2020 and that the Medical Devices Directives will be repealed one year later on the new date of application of the MDR. EC announcement can be viewed via link here https://bit.ly/2xgRpUq.

Last weeks round-up; 20 – 24 April 2020

MHRA NEWS: EXCEPTIONAL GMP FLEXIBILITIES FOR MEDICINES MANUFACTURERS DURING THE CORONAVIRUS (COVID-19) OUTBREAK

MHRA has updated its guidance on the GMP flexibilities it is allowing on an exceptional basis during the current pandemic. The flexibilities cover two main areas relate to manufacture and importation, and pharmaceutical quality system topics. However, it is stressed that implementation of any described flexibilities is contingent on Qualified Person input to that decision. The guidance also requests companies to speak with MHRA where these flexibilities are not sufficient to overcome current challenges. The full text detailing the specifics can be found here https://lnkd.in/da22tgr

EMA NEWS: 2020/2021 DEADLINES FOR SUBMISSION OF APPLICATIONS FOR OMPD AND CORRESPONDING COMP TIMETABLE

EMA has just updated the deadlines for submission of applications for orphan medicinal product designation to the EMA and corresponding COMP timetable for valid applications, full tabulated details can be found at this link https://lnkd.in/dhRqpEh

EMA PRIVACY STATEMENT – EUROPEAN UNION ELECTRONIC REGISTER OF POST – AUTHORISATION STUDIES

The European Medicines Agency (EMA) has issued a privacy statement regarding the EU PAS Register®. The latter is a publicly available database to provide a register of non-interventional post-authorisation studies (PAS). The Privacy Statement explains the most essential details of the processing of personal data by the EMA in the context of the European Union electronic Register of Post-Authorisation Studies (EU PAS Register), the full statement can be found under the following link; https://lnkd.in/dxK4TAG

Last weeks round-up; 30 March – 3 April 2020

EMA ADOPTS ICH GUIDELINE S11 ON NONCLINICAL SAFETY TESTING IN SUPPORT OF DEVELOPMENT OF PAEDIATRIC PHARMACEUTICALS

EMA has adopted the ICH S11 guideline. It is due to come into effect on 26th September 2020. The guideline provides direction on the nonclinical safety studies important to support a paediatric development program. It will recommend standards for the conditions under which nonclinical juvenile animal testing is considered informative and necessary to support paediatric clinical trials, and also provides guidance on the design of the studies. A streamlined drug development and higher scientific rigor while minimizing the unnecessary use of animals will be achieved with the implementation of this new harmonised ICH guideline. The full text can be found here https://lnkd.in/dbkTrr2

EMA BIOLOGICALS WORING PARTY (BWP) HAS PUBLISHED ITS RECOMMENDATIONS FOR THE SEASONAL INFLUENZA VACCINE COMPOSITION FOR 2020/2021 SEASON

The BWP was convened in order to recommend the virus strains for the manufacture of seasonal influenza vaccine for 2020/2021. Having considered the information on international surveillance by WHO presented by the representative of the WHO Collaborating Centre for Reference and Research on Influenza at the Francis Crick Institute (UK), the CHMP BWP Ad hoc Influenza Working Group, consisting of experts on influenza from the Member States, considered that the WHO recommendation on the composition of vaccines for 2020/2021 should be followed. The recommendations can be found under this link https://lnkd.in/dSgTVp4

EMA: FEES INCREASE 1ST APRIL 2020

The EMA has announced that general fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.6% on 1 April 2020. Full details of the new fee levels are available in Commission Regulation (EU) No 2020/422 amending Council Regulation (EC) No 297/95, its implementing rules and the corresponding explanatory note on fees, published on 19 March 2020. These documents include the new fees for all types of procedures handled by the Agency, except for pharmacovigilance procedures. Every year, the Agency adjusts its fees on 1 April, in line with the European Union (EU) inflation rate for the previous year. The current increase reflects the inflation rate for 2019, as published by Eurostat, the EU’s statistical office. https://lnkd.in/eJFEjHQ

ICH: EC AND EMA IN COLLABORATION WITH EU MEMBER STATE, ADEQUATELY IMPLEMENT AND ADHERE TO  ICH GUIDELINES

ICH has issued the results of a survey, which show that the EC and EMA, in collaboration with EU Member States, adequately implement and adhere to ICH guidelines, without introducing unjustified modifications: Adequacy of Implementation and Adherence to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines: centralised procedure with EMA. https://lnkd.in/eiAUGbb These results are part of a 2019 study to monitor the adequacy of implementation and adherence to ICH guidelines in regulatory member and observer countries and regions. The study report provides a gap analysis based on authorities’ and companies’ views on the implementation and adherence of regulators to ICH guidelines. It reveals a close alignment between the self-declaration of the authorities and perception among companies. For more information, see ICH guideline implementation on the ICH website. https://lnkd.in/efGNCwZ

EMA: ADVANCING REGULATORY SCIENCE IN THE EU: NEW STRATEGY ADOPTED

EMA has published its Regulatory Science Strategy to 2025 on 31st March 2020. It comes in response to the dramatic acceleration of the pace of innovation and the need to support the development of increasingly complex products, especially in the light of the ongoing COVID-19 pandemic. One of the fundamental principles of the strategy is the need for rapid and close engagement of all stakeholders and partners. The learnings from the handling of this public health crisis will be incorporated in ongoing adaptations in real-time. The five key goals of the strategy include: catalysing the integration of science and technology in medicines development; driving collaborative evidence generation – improving the scientific quality of evaluations; advancing patient-centred access to medicines in partnership with healthcare systems; addressing emerging health threats and availability/therapeutic challenges; enabling and leveraging research and innovation in regulatory science. https://lnkd.in/gXXxV2r

HPRA – APPLICATION BY A MANUFACTURER FOR A REGULATORY DEROGATION FOR A NON-CE MARKED MEDICAL DEVICE FOR COVID-19

HPRA issued form ‘Application by a Manufacturer for a Regulatory Derogation for a non-CE marked Medical Device for COVID-19’ on the 24th March 2020 for manufacturer’s to apply to HPRA for permission for use of their non-CE marked medical device(s) by healthcare professionals in the context of COVID-19 outbreak. The form is intended to speed up the process of use of devices for COVID-19 and must be completed by the manufacturer or their authorized representative. The form is available from the following link https://lnkd.in/eYAjh-C

EMA TO ISSUE ELECTRONIC CERTIFICATES FOR MEDICINES

From 30th March 2020 EMA has implemented a new system to issue electronic certificates for human and veterinary medicines. EMA will no longer provide printed certificates. This will allow the agency to maintain the ability to provide these documents during the COVID-19 pandemic. The new format of the certificates is based on an electronically signed PDF document and will apply to all ongoing and future requests. The Agency will also consider whether the electronic signature should be implemented as a permanent solution as part of its efforts to digitalise its administrative processes for all documents requiring signature. Questions on the new electronic certificates can be sent by email to: certificate@ema.europa.eu. More information on the certification of medicinal products is available on EMA’s website.

Last weeks round-up; 16 – 20 March 2020

REAL REGULATORY IS FULLY OPEN FOR BUSINESS

Real Regulatory has long since had the systems in place to support our clients on a remote basis while our staff too have always had the flexibility to work remotely. At this time, our priority is the safety of our team and the continuation of our high quality services for our customers. In order to protect our fantastic staff and to ensure business continuity, all of our consultants are working from home. We are, as ever, always available if you need support during these times and available to help on an interim or ongoing basis. If you have any queries related to your projects, please don’t hesitate to chat to us: https://lnkd.in/eFeHweG

MHRA CASE STUDY: MHRA’S SPEEDY APPROVAL OF HIGH DOSE FLU VACCINE DEMONSTRATES FLEXIBILITY IN NATIONAL APPLICATIONS

The UKs MHRA has a published a case study detailing how the agency approved a flu vaccine within 7 months rather than the usual 12 month turnaround. Since the 2018 to 2019 flu season, a vaccine specially designed to have optimal efficacy in the elderly has been available for preferential use in the over-65s. More details of the specific case can be found here https://lnkd.in/dkJSuNx The agency is very keen to demonstrate their agility, flexibility and willingness to collaborate with industry. If you need any help with the agency dialogue or need a UK/EU based company entity to become temporary licence holder for your product application. Please contact RRL https://lnkd.in/daQjxxj

MHRA ADVICE: ADVICE FOR MANAGEMENT OF CLINICAL TRIALS IN RELATION TO CORONAVIRUS

MHRA has issued comprehensive advice on managing clinical trials during the period of restrictions imposed as a result of COVID19. Importantly, MHRA has clarified that ‘An increase in protocol deviations in relation to Coronavirus will not constitute a serious breach, therefore there is no need to report this to us (unless of course patients are being put at risk).’ MHRA has specified that prospective protocol waivers remain unacceptable, they would not expect companies to bypass the eligibility process due to difficulties in assessing subjects and carrying out tests. Safety of patients remains a priority and they should not be included into a trial unless they meet the inclusion and exclusion criteria. If the safety of a trial subject is at risk because they cannot complete key evaluations or adhere to critical mitigation steps, then consideration to discontinuing that subject must be discussed, which may also extend to the whole trial in some cases. Urgent Safety Measures may be used to halt, or even temporarily halt a trial, or halt recruitment. A temporary halt, including for logistical reasons such as trial team unavailability, should be submitted as a substantial amendment. http://bit.ly/2Wq7LEg

MHRA INSPECTORATE BLOG: GCP INSPECTIONS: EXPECTATIONS AND THE DOS AND DONT’S OF HOSTING

Inspections are an opportunity to demonstrate your organisations compliance to GCP. Inspectors will always be open and honest, and likewise is expected from the organisations. Inspections and how they are conducted has evolved over the years and has had to, due to the increased complexity of trials, organisations, implementation of electronic clinical trial systems and the development of technology. No longer are trial teams based in one office with a single paper trial master file (TMF). Issues are often encountered during the inspection with TMF access and navigation, document request provision and sometimes simply finding the right person to answer a particular question. This can be frustrating for both parties and may even lead to the extension of the inspection. MHRA has issued a of the dos and don’ts and questions to raise through each phase of the process of conducting a GCP inspection. Full details of the recommendations can be found under this link https://lnkd.in/dX-fast

SAFETY FEATURES FOR MEDICAL PRODUCTS – HUMAN USE

All stakeholders can keep up to date on implementation of technical aspects of Regulation EU 2016/161 via Q&A Document Safety Features for Medicinal Products Human Use updated on the 9th March 2020 to v17 and linked here https://bit.ly/2U6kKIj.

Wholesalers are referred to Section 5 of the Q&A document which addresses VERIFICATION OF THE SAFETY FEATURES AND DECOMMISSIONING OF THE UNIQUE IDENTIFIER BY WHOLESALERS, in particular newly added Q&A 5.11 below 5.11. Question: Should wholesalers be connected to the national repositories or can they be connected to the European hub? A wholesaler physically holding products and performing activities related to wholesale outlined in Articles 20-23 Commission Delegated Regulation (EU) 2016/161 (such as the verification of returns or decommissioning for export) should be connected to and perform operations in the national repository where the activities take place.

A connection to the national system is necessary to ensure that the audit trail is accurate and complete. Stakeholders all have an important role to play in implementation of Regulation EU 2016/161 to ensure that public health is safeguarded by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines.

Last weeks round-up; 9 – 13 March 2020

EMA UPDATE: GUIDANCE ON THE PILOT FOR SIMULTANEOUS NATIONAL SCIENTIFIC ADVICE

EMA has issued an update to the guidance for applicants for the pilot simultaneous national scientific advice (SNSA) process, which is now live. The changes do not look to be anything more than formatting edits (please correct us if we are wrong). So perhaps they are trying to increase the uptake. The process itself is well described in the document which can be found under this link https://lnkd.in/d76bDmG

EMA NEWS: VIRTUAL EMA MEETINGS UNTIL END OF APRIL 2020

In order to limit international travel and the number of visitors going to the offices, and to reduce the risk of an infection with the novel coronavirus for delegates, visitors and staff, EMA has advised that all meetings of EMA committees and working parties will be held virtually until the end of April 2020. In addition, stakeholder events hosted by EMA which were planned to take place at the Agency’s premises in Amsterdam in March and April will either be held virtually or postponed until later in the year. Participants of these meetings will be informed directly about this decision. EMA’s plans are being continually reviewed. The dedicated webpage on COVID-19 is updated as the situation develops. https://lnkd.in/dx4cjB3

Last weeks round-up; 2 – 6 March 2020

RECOMMENDATIONS ON THE ELIGIBILITY TO PRIME SCHEME ADOPTED AT THE CHMP MEETING OF 24-27 FEBRUARY 2020

The recommendations on eligibility to the PRIME scheme adopted at the CHMP meeting of 24-27 February 2020 has been posted on the EMA website, along with the cumulative overview of recommendations on PRIME eligibility requests adopted since the scheme began in 2016. In keeping with the usual proportion of grants and denials, of 5 applications for the month, 1 was granted whilst 4 were denied. The one granted is a gene therapy for “treatment of X-linked Retinitis Pigmentosa owing to defects in Retinitis Pigmentosa GTPase Regulator” supported by clinical exploratory data. The four that were denied are chemical substances, all of which also included clinical exploratory data, in the therapeutic areas of cardiovascular diseases, gynaecology, endocrinology, and neurology. For further details, please click: https://lnkd.in/ePz256f

FINAL VERSION OF ICH GUIDELINE Q12 HAS BEEN PUBLISHED

ICH Q12 covers technical and regulatory c onsiderations for pharmaceutical product lifecycle management. It has been in the works for quite a while and is intended to globally harmonise the management of post-approval changes to chemistry, manufacturing and controls (CMC). However, there are some conceptual differences between ICH Q12 and the current EU legal framework, meaning that there are limitations on how fully ICH Q12 can currently be implemented within the EU.

Incompatible sections are those on scientific risk-based approaches to defining established conditions and associated reporting categories (described in Chapter 3.2.3 of the new guideline) and on the product lifecycle management document (PLCM, described in Chapter 5). Within the EU, regardless of the current text within ICH Q12, the definition of established conditions and their reporting categories must follow the requirements laid down in the current EU Variations Regulation and associated EU guidelines. The PLCM cannot currently be recognized if submitted. https://lnkd.in/g2vefsg

EMA NEWS: QUALIFICATION OF NOVEL METHODOLOGIES FOR MEDICINE DEVELOPMENT

EMA has just published the adopted Qualification Opinion on the Multiple Sclerosis clinical outcome assessment (MSCOA) and an overview of comments received. The intent is for this COA instrument to serve as a primary, co-primary, or secondary endpoint to assess efficacy in clinical trials at various stages of drug development, including proof of concept, dose-ranging, confirmatory and registration trials. There are four specified performance outcome measures assessing important dimensions of multiple sclerosis (MS), which are considered as a battery of tests, some or all of which could be used as a dysconjugate composite endpoint by sponsors in a clinical trial. Full details are available here  https://lnkd.in/d_WeSAN

EMA: ANNUAL REPORT ON THE USE OF THE SPECIAL CONTRIBUTION FOR ORPHAN MEDICINAL PRODUCTS DURING 2019

An important incentive offered by the legislation is the possibility for sponsors of orphan medicinal products to receive reductions in the regulatory fees payable to the Agency. A special contribution is allocated annually to the Agency by the European Union (EU) for fee reductions for orphan medicinal products. Since the year 2000, over 2,233 orphan designations have been issued by the European Commission, of which so far 169 have resulted in authorised medicinal products. This link https://lnkd.in/ddDfHfV presents a nice table detailing the EMA policy on the level of fee reductions reflects the priority given to ‘protocol assistance’ and the support to small and medium-sized enterprises (SMEs) and other information on the scheme. EMA has issued this updated presentation on the statistics for Orphans https://lnkd.in/gt-xChE

EMA ISSUES A PRESS RELEASE ON RECENT ORGANISATIONAL CHANGES

The purpose of the re-organisation has been stated as to ensure that the Agency operates as efficiently as possible, taking into account the rapidly evolving landscape for pharmaceutical research and development, and driven by the need to recalibrate to a lower head count following the relocation of the Agency to Amsterdam in 2019. Several org charts have been issued. A new EMA org chart  https://lnkd.in/ejYBSyJ, where operations in the area of human medicines have been integrated into one Human Medicines Division, which will be led by Alexis Nolte. In addition, four mission-critical task forces have been established to support the human and veterinary medicines divisions. Here is a link to the new task forces org chart  https://lnkd.in/esvDkNe. Updates to the existing org charts for Stakeholders & Communication Division, Information Management and Advisory functions have also been issued and can be found on the site.