Last weeks’ round -up;
21 December -08 January 2021

MHRA advice for prevention of fraudulent representation

The MHRA Inspectorate has released a blogpost on the qualification and re-qualification of suppliers and customers, which are one of the highest risk areas of good distribution practice (GDP). The article focusses on the online resources that suppliers and customers make available and advises stakeholders to be mindful when publishing company information online, in order to avoid attempts of false representation by fraudsters. Vigilance and diligence are required when conducting bona fide checks of customers and suppliers to maintain the integrity of the legal supply chain of medicines and preventing falsified medicines from entering the supply chain.

https://bit.ly/RealCMC-35nMT4d

Updated Ph. Eur. General Chapter 2.9.2 Disintegration of Suppositories and Pessaries

A draft revised Ph. Eur. General Chapter 2.9.2 Disintegration of Suppositories and Pessaries has been published in Pharmeuropa 33.1. The document is available with tracked changes and is open for consultation until 31st March 2021.

http://bit.ly/RealCMC-38btoOf

MHRA: UK Innovative licensing and Access Pathway (ILAP) for Medicines

In keeping with the wish to maintain its position as a top tier regulatory agency, the MHRA has set out details of its new Innovative Licensing and Access Pathway (ILAP) process. The release details the medicines that are eligible for the new pathway and what is on offer to those medicines which are accepted. It is intended that the process will allow very early entry, based on non-clinical data, as well as catering for products with mid-development ‘global’ dossiers. To maximise the benefits, applicants are encouraged to apply early. Those that are towards the end of their development programme are generally not suitable. The ILAP will be operational from 1 January 2021 and the application form and more details of the process will also be released on this date. Until then the detail release can be accessed here: https://lnkd.in/e5eiyij

UK MHRA issues new guidance on submitting clinical trial safety reports from 1 Jan 2021

UK MHRA has published new guidance on how to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports / Development Safety Update Reports (DSURs).

https://lnkd.in/e3YKf-J

(more…)

Last week’s round -up;
07-11 December 2020

Brexit – Article 41 of the Withdrawal Agreement

The EC and EMA have published a notice to stakeholders titled ‘Withdrawal of the United Kingdom and EU Rules for Medicinal Products for Human Use and Veterinary Medicinal Products’ (Rev 3, dated 13 March 2020). Article 41 of this agreement indicates that medicines, which are certified by a Qualified Person and have been released in the United Kingdom for sale or supply before 11 pm on 31 December, can be supplied to the Irish market after the transition period ends. The receiving site in Ireland must ensure that certain requirements, described in the following article, are met: https://bit.ly/RealCMC-39ZZkGt

New Ph. Eur. general chapter for the analysis of N-nitrosamine impurities

The Ph. Eur. Commission has adopted a new general chapter on the analysis of N-nitrosamine impurities in active substances (2.5.42). The general chapter covers the different needs of control laboratories as it proposes three procedures which rely on different instruments (GC-MS, LC-MS/MS and GC-MS/MS). The chapter focuses mainly on the analysis of N-nitrosamine impurities in angiotensin-II-receptor antagonists (sartans) containing a tetrazole group, including valsartan, losartan potassium, candesartan cilexetil, irbesartan and olmesartan medoxomil. However, the procedures may also be applied to other substances or to medicinal products following demonstration of suitability for the intended purpose with additional validation.

https://bit.ly/RealCMC-3n6sfwa

Joint published EMA and HMA strategy sets direction for EMA and EU medicines regulatory agencies to 2025

The European Medicines agency and Heads of Medicines Agencies, have published their joint strategy for the next 5 years. It lists 6 areas of priority, availability and accessibility of medicines; data analytics, digital tools and digital transformation; innovation; antimicrobial resistance and other emerging health threats; supply chain challenges; and finally the sustainability of the network and operational excellence. Emer Cooke, EMA’s Executive Director commented that “The COVID-19 pandemic has highlighted the pivotal role of medicine regulation for the protection of public health,” and “This strategy ensures that we join forces across the EU to effect tangible improvements for citizens.”

Full details of the news item and a link to the strategy document can be found here: https://lnkd.in/eK-_MQq

(more…)

TOPRA 2020 Goes Online, We’ll be There

Will you be attending this year’s fully online TOPRA Symposium?

The Annual TOPRA Symposium brings together the pharmaceutical, medical device and veterinary medicines communities.  It is the first-choice key event in the European regulatory affairs calendar for anyone working as, or alongside, regulatory professionals.

Chat to our team about how we can produce bespoke strategies no matter what phase of development, ensuring swift and timely approvals.

We look forward to seeing you there! To arrange a meeting at a time convenient to you, contact us today.

Last week’s round-up;
06-10 July 2020

167th session of the Ph. Eur. Commission

The Ph. Eur. Commission held its 167th session on the 23 June 2020. Due to restrictions imposed by the COVID-19 pandemic the session was held online to ensure continuity of the work of the Ph. Eur. Commission. During the session, the Commission adopted 75 texts for publication in Ph. Eur. Supplement 10.5, including 64 revised texts and 11 new texts, including a revised text on Parenteral Preparations (0520) which had been significantly modified to update the requirements for testing for visible and subvisible particles, the definitions given and the uniformity requirements. The adopted texts will come into effect on the 1st July 2021. The next session of the Ph. Eur. Commission will take place in November 2020.

https://bit.ly/RealCMC-2ZgUj6w

EC Health Safety Committee (HSC) meeting summary report

The ECs HSC has issued a brief summary report following its recent audio meeting. In it the EC presented the revised vaccination plan blueprint for COVID-19, including major points on objectives, vaccination coverage, priority groups and number of doses needed for the EU, as well as comments received from the HSC. Other main topics included discussions on risk assessment for resurgence of the virus, exit strategies for lockdowns, impact of deconfinement measure and superspreading events.

The report can be found under this link:  https://lnkd.in/ehC-WCY

Q&A on ICH M7

The EMA has released a questions & answers document on ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk (step 2b). This document is intended to provide additional clarification and to promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities. It also provides further insight into the information that should be provided during drug development, marketing authorization applications and/or Master Files. The EMA’s questions & answers document is open for public consultation until the 3rd October 2020.

https://bit.ly/RealCMC-2CnPj76

EUnetHTA launches its COVID-19 related repository of publications and outputs

EUnetHTA, the European Network for Health Technology Assessment, has just launched a repository of related material for the COVID-19 pandemic. This responds to the EC communication on “Guidelines on COVID-19 in vitro diagnostic tests and their performance”, and is linked to the database recently set up by JRC devoted to testing devices. The repository gathers publications by EUnetHTA and by HTA organisations on testing methods and devices, treatment options, and other public health measures relevant to COVID-19.

A link the repository can be found here:  https://lnkd.in/eUvnJUV

EMA issues a new medicines agency network strategy to 2025.

Recognising that the current challenges we face go well beyond the remit of medicines regulation, and will need to be addressed by the EU and its Member States as a whole and individually. Learning from this experience presents an opportunity to shape the future role of medicines regulation nationally and at the EU level, and enhance the partnership approaches that we need to ensure that we are proactively positioned to deal with similar emergencies.A new European medicines agencies network strategy to 2025 has been issued by EMA setting the direction for the Network’s response. It focuses on areas such as; Availability and accessibility of medicines; Data analytics, digital tools and digital transformation; Innovation; Antimicrobial resistance and other emerging health threats; Supply chain challenges; Sustainability of the Network and operational excellence.

The document and a public consultation on the strategy have been launched on the EMA site under this link https://lnkd.in/e3PcWcD

Lapatinib product-specific bioequivalence guidance

The second draft of the EMA’s Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance is available for public consultation until the 30th September 2020. A second public consultation of the guidance is underway as the first draft was significantly revised in response to the comments received during the first public consultation.

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

EMA issues first edition of the Clinical Trial Information Systems (CTIS) Newsletter

As reported last week, EMA has now issued the first edition of the CTIS Newsletter as we move towards the go-live of this eagerly awaited IT system. It is envisaged to be issued on a twice yearly basis.

The newsletter in full can be found under this link https://lnkd.in/ec9sBH6

Ph. Eur. updates

The following information regarding Ph. Eur. Supplement 10.3 has been published: · The contents of the supplement. The document includes a list of new and revised texts which will be implemented by the 1st January 2021, a list of corrected texts which should be taken into account by the 31st August 2020, as well as texts whose titles have changed and deleted texts. · New reagents have been added to the list of reagents published in chapter 4 of the Ph. Eur. · Comments concerning revised texts published in Supplement 10.3. This document contains details of the technical modifications that have been made to the revised texts.

Further details concerning these Ph. Eur. updates may be viewed here: https://bit.ly/RealCMC-38zsVEa

EMA endorsement of joint statement on prioritisation of COVID-19 clinical trials

The EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Its underlying aim is to step up global collaboration, facilitation and evaluation of COVID-19 treatments. Within the statement, key characteristics of clinical trials that enable accelerated approval are described. These include robust methodology and endpoints, realistic recruitment and completion capacity, and testing of repurposed drugs or those at advanced stages of development. Treatments addressing the most severe complications of COVID-19 and those with simpler routes of administration and treatment duration are also highlighted for priority.

https://lnkd.in/g9aZbu3 (more…)

Real Regulatory to attend this year’s fully virtual ON Helix 2020

Will you be joining  this year’s ON Helix 2020?

Presented by One Nucleus, this year’s ON Helix conference is fully committed to bringing the insights and connections needed to understand innovation in translational research and support R&D companies in their current and future therapeutic and technology developments.

In an entirely virtual meeting format, both speakers and attendees will be participating remotely via a digital platform.

Our expert, Leslie Dowling, will be casting in. Chat to her about how we can support your internal team efforts.

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

Last week’s round-up; 4 – 8 May 2020

COVID-19: EMA FAST TRACKS SUPPORT & APPROVAL OF MEDICINES & VACCINES

EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures described in the inventory https://lnkd.in/deaz5Ki can accelerate every step of a medicine’s regulatory pathway and the Agency is fully mobilised to deliver these fast-track assessments in the shortest possible timeframes while ensuring robust scientific opinions are reached. The text of the press release can be found under https://lnkd.in/d-qhK4B

EXPEDITED REVIEW FOR A PIP, DEFERRAL OR WAVIER FOR TREATMENTS AND VACCINES FOR COVID-19

In particular, EMA will review applications for a PIP, deferrals or waivers for treatments and vaccines for COVID-19 in an expedited manner, in order to speed up an approval. The compliance check can also be expedited, if needed. For these products,

      1. No pre-specified PIP submission deadlines;
      2. Review of a PIP is reduced to a minimum of 20 days;
      3. EMA decision following a review is reduced to 2 days;
      4. Compliance check can be reduced to 4 days.

 

There is also a possibility for the developer to provide a focused scientific documentation, to be agreed on a case-by-case basis. Full details can be found under this link https://lnkd.in/d2SRyn8

UPDATED SAWP 2020 MEETING DATES

EMA’s Scientific Advice Working Party (SAWP) has updated meeting dates in September 2020. The full tabulations under link https://lnkd.in/djmCNCP include deadlines for submissions for scientific advice, protocol assistance, qualification of biomarkers and parallel consultation EMA/EUnetHTA requests.

ICH Q3C (R6) RESIDUAL SOLVENTS

An updated draft of the impurities guideline for residual solvents, ICH Q3C (R8), has been published. ICH Q3C recommends acceptable amounts for residual solvents in pharmaceuticals, and this draft only contains information on three additional solvents: 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol.

The Permitted Daily Exposure (PDE) for each has been set at 50mg/day, 15mg/day and 35mg/day respectively. The document is open for consultation until 30 July 2020. Once agreed upon, this data will be integrated into a complete ICH Q3C (R8) guideline document: https://lnkd.in/gEh9PGU

CLINICAL PHARMACOLOGY AND PHARMACOKINETICS: Q & A

The EMA has released a new Clinical pharmacology and pharmacokinetics Question & Answer. The new Q&A (4.12) clarifies the EMA’s position on the demonstration of bioequivalence for the anticoagulant drug dabigatran etexilate. The following clarifications are provided:

        • A bioavailability study under fed conditions may not replace the comparative bioavailability study with proton pump inhibitors.
        • Dissolution tests at various pHs may not replace the comparative bioavailability study with proton pump inhibitors.
        • Demonstration that the effect of proton pump inhibitor on the bioavailability of dabigatran is equal or less than for the innovator product, is not sufficient.

 

Bioequivalence should also be demonstrated in the presence of proton pump inhibitors. Further details are available here: https://lnkd.in/ghYb-vP

NEW MODEL OF GI TRACT COULD SPEED DRUG DEVELOPMENT

A promising new model of the gastrointestinal tract could speed up drug development. Created by MIT engineers, the model tests how well drugs are absorbed in the small intestine and should help oral drug formulation. The model uses pig intestinal tissue, and more closely replicates the human intestine than the currently used approach of testing these formulations in human colorectal cancer cells.

The system can be used to test up to 10,000 samples per day and its results have been found to be 90% accurate, through tests carried out using 60 drugs already approved by the FDA. In contrast, tests using colorectal cancer cells have a near 50% percent accuracy: https://lnkd.in/gRiw-zy

FDA DRAFTS GUIDANCE ON EMERGENCY-USE INJECTOR RELIABILITY

The FDA has released draft guidance explaining how combination product developers can demonstrate that their emergency-use injectors will reliably deliver drugs as intended in a life-threatening emergency. The draft guidance specifically applies to emergency-use injectors that are prefilled or co-packaged with emergency drugs or biologics. The document expands on FDA’s ‘Technical Considerations for Pen, Jet, and Related Injectors for Use with Drugs and Biological Products’ guidance that was released in 2013.

The “FDA recommends that emergency-use injectors include design control specifications for successful injection reliability of 99.999% with a 95% level of confidence”, which ensures that the emergency-use injector performance is as safe and reliable as possible as well as feasible. The guidance also provides a model for establishing reliability and recommendations for completing a reliability report to submit premarket submissions for these products. https://bit.ly/3dlH6xs

EC: Q & A ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING COVID-19

The European Commission has released some new questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. The document includes the following guidance (questions 2.2 – 2.4) on the manufacturing and importation of finished products and active pharmaceutical ingredients:

 

The EC has released the above guidance in order to prevent disruptions in the availability of medicines during the pandemic. https://bit.ly/2VYSVnu

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; 13 -17 April 2020

HPRA NEWS: EXPEDITED REGULATORY AND ETHICS REVIEW IN IRELAND

The HPRA, in conjunction with the Department of Health, the National Office for Research Ethics Committees and the Health Research Declaration Committee (HRCDC), have agreed an expedited review process for human health research related to the current pandemic, further details can be found here https://bit.ly/2Kaun4g. A key development is the establishment of a dedicated COVID-19 national research ethics committee (NREC-COV19) by the Minister for Health. In the interests of time and resource efficiency, applications for ethical review of all human health research studies related to COVID-19 should be submitted to the NREC-COV19. Applications for clinical trials of human medicines, or clinical investigations of medical devices, will be given a priority and expedited review by the HPRA and the NREC-COV19 will review applications concurrently with regulatory review processes and will endeavour to facilitate an expedited ethical review. https://bit.ly/2KbtXuq

EMA INSPECTIONS OFFICE, NOTICE TO SPONSORS ON VALIDATION AND QUALIFICATION OF COMPUTERISED SYSTEMS USED IN CLINICAL TRIALS

Given recent inspection findings and the implications they have had on the integrity, reliability, robustness and acceptability of data in the context of MAAs, the GCP Inspectors Working Group (IWG) in cooperation with the Committee for Medicinal Products for Human Use (CHMP) sees the need to emphasize requirements for sponsors/vendors providing computerised systems or services as well as for the qualification and validation of computerised systems used to manage clinical trial data. The notice stresses “Data integrity, reliability and robustness will depend on the design and the validation status of the computerised systems used. Failure to document and therefore demonstrate the validated state of a computerised system is likely to pose a risk to data integrity, reliability and robustness, which depending on the criticality of the affected data may result in a recommendation from the GCP inspectors to the CHMP not to use the data within the context of an MAA.” The full text is available here https://lnkd.in/e8PfiZ5 and also refers the reader to Q8 and Q9 from the good clinical practice (GCP) Q&As published on the EMA website.

EMA SUBMISSION DEADLINES FOR PAEDIATRIC APPLICATIONS 2020/2021

EMA has just published its submission deadlines for PIP applications for the period 2020/2021. The tabulation can be found here https://lnkd.in/e2hbhUz. Please also note that, per our previous post on 25th March 2020, a letter of intent for PIPs and PIP waivers is no longer required.

EC NEWS: COVID-19: GUIDANCE ON MORE REGULATORY FLEXIBILITY FOR MEDICINES

The European Commission, EMA and the European medicines regulatory network have developed a Q&A document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document published today outlines areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders may be faced with in the context of COVID-19. The document outlines areas where regulatory flexibility is possible to address some of the constraints marketing authorisation holders may currently be faced with. https://lnkd.in/d5SY6z2

EMA HAS ESTABLISHED A COVID-19 EMA PANDEMIC TASK FORCE (COVID-EFT)

EMA has issued a document outlining the ‘Mandate, objectives and rules of procedure of the COVID-19 EMA pandemic Task Force (COVID-ETF)’. EMA has the mandate under the Health Threat plan to convene specific expert groups such as the EMA Task Force (ETF) to assist the CHMP, PRAC and PDCO or take part on behalf of the CHMP in early scientific discussions and products reviews as needed. This methodology has helped greater coordination in previous outbreaks. In the context of the COVID19 pandemic, and following a call from Member States (MSs) and European Institutions, the composition and the objectives of the ETF have been modified in order to better support the regulatory activities and public health needs of the Member States and the European Commission during this pandemic. Full details can be found https://lnkd.in/dz6BV8J

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.

Search Real Regulatory