SME Archives - Real Regulatory

The following draft revised monographs (with tracked changes) have been published in Pharmeuropa. The draft monographs are available for public consultation until 31st March 2021.

EMA News: EMA announces detail approach on training for the new Clinical Trial Regulation CTIS portal.

In anticipation of CTIS go-live in Dec 2021 to support implementation of the CTR, online training modules are foreseen from 21st Jan to ensure equal access for all. Once launched, CTIS will be immediately available for authorities and clinical trial sponsors, with a 3 year phased transition period from the current Directive 2001/20/EC. EMA plans 3 training streams

3. Targeting different forms of end-users on role specifics (e.g. admin, preparer, submitter).

Real Regulatory has SME status and will initially train on the 2nd stream. Training and our current involvement in pilot schemes now available will mean we can continue to provide best support to our clients.

EMA News: EMA has issued a new draft guidance on the Module 3 quality support packages required for MAAs of PRIME Designated Medicines.

PRIME was launched to enhance EMA support to the development of medicines that target an unmet medical need. EMA has just published a draft guidance on scientific elements and regulatory tools to support quality data packages for applications to the scheme. This should serve as a toolbox for building Module 3 quality data packages in the preparation of marketing authorisation applications (MAAs) of designated PRIME medicinal products.

EMA News: EMA has published detailed accelerated assessment timetables for ATMP full MAAs

The EMA has published a new document which details timetables for full MAA procedures for Advanced therapy medicinal products (ATMPs). Timings extend through to end of 2024, and include assessment of the initial submission (120 day timetable) and timings for assessment of responses to list of questions (30 day timetable after clock-stop).

UK MHRA updates Pharmacovigilance System requirements

Following user feedback, the MHRA have edited some of their guidance on Qualified Person responsible for Pharmacovigilance (QPPV) and pharmacovigilance system master files (PSMF) to make it easier to understand and to provide clarification on certain points. The updated guidance can be found here: http://bit.ly/3cAuxkU

UK MHRA publishes the submission dates for the new UK national MAA 150-day procedures

Marketing Authorisation Application submission dates for the new 150-day national and European Commission decision reliance procedures and guidance on how submissions using the EC decision reliance procedure work have been published on the MHRA website, and can be found here: http://bit.ly/3j8GNua

Updates from the EDQM

The EDQM has recently released the ‘New European Pharmacopoeia Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances’.

• European Paediatric Formulary: Phosphate Oral Solution open for public consultation in issue 3 of Pharmeuropa PaedForm (17-Dec-20)

• European Pharmacopoeia Commission adopts new general chapter Contaminant pyrrolizidine alkaloids (2.8.26) (05-Jan-21)

• Pharmeuropa 33.1 just released: don’t miss this opportunity to provide your comments (06-Jan-21)

• Brexit: End of mutual recognition of Official Control Authority Batch Release between the EU/EEA and the UK (08-Jan-21)

• Adoption of Fritillariae thunbergii bulbus describing alternative quality control test (15-Jan-21)

• Implementation of the European Pharmacopoeia Supplement 10.5 – Notification for CEP holders (18-Jan-21)

• CEP holders invited to comment on draft monographs published in Pharmeuropa 33.1 (20-Jan-21)

Last week’s round-up;
26 – 30 October 2020

New FDA Guidance on Referencing Approved Drug Products in ANDA Submissions

The US FDA has published a ‘Referencing Approved Drug Products in ANDA Submissions Guidance for Industry’. The guidance provides some clarifications to potential applicants who wish to seek approval for generic medicines on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an ANDA submission. The FDA also provides recommendations on how applicants can accurately use these terms in an ANDA, how applicants can request FDA designation of an RLD, and how FDA selection of a reference standard may be requested. The recommendations in the document are nonbinding.

EMA’s implementation plan to address nitrosamine impurities

The EMA has released its full plan to implement recommendations to reduce the risk of nitrosamine contamination in medicines. The Agency’s plan specifies the short-, medium- and long-range priorities. The plan is based on the June 2020 “lessons learned” report from the European Medicines Regulatory Network on the problem of pharmaceutical contamination with nitrosamine impurities. It includes 40 separate recommendations and corresponding actions from the report and for each recommendation the plan identifies a lead agency, other involved parties and a timeline. The EMA’s plan also recommends that assessors are appropriately trained to ensure that the recommendations concerned are implemented in the review of MA or variation applications. A detailed question-and-answer document is also in the pipeline within the next 12 months and will provide information about potential sources of nitrosamine impurities, as well as other substances of concern.

EMA issues a reflection paper on development of Medicines for use in older populations

The email has issued a new and most interesting reflection paper on the development of Medicines for use in older populations.It is interesting from the perspective that whilst the main audience of the envisaged new guidance is the medicines developers, the concepts may too be of interest to other stakeholders such as physicians, pharmacists and patients because of topics such as patient adherence, medication safety and practical medication problems. Rather than focusing solely on chronological age, it states it is more important to focus on biological age of the patient. Therefore, the paper recommends to take a patient-centric approach to pharmaceutical development as the model approach. In addition, companies are encouraged to seek scientific advice in order to design, from the beginning, a medicine portfolio that takes into account as much as possible, the disease, disease setting and the needs of any patient, including older people with comorbidities and polypharmacy.

MHRA UK and EU Transition: new rules for 2021

There are some recent updates on the MHRA site, regarding new assessment routes, procedures for PIPs, conversion of Centrally Authorised Products to GB Marketing Authorisations (as communicated with Marketing Authorisation Holders), and also a change regarding Falsified Medicines Directive. Please note that although MHRA has been publishing some guidance, they have also been busy updating all guidances. However, a number are being held subject to agreement between the parties currently negotiating the final deal between UK and EU. It was due to happen by mid-Oct, which is why they planned a series of webinars on various topics which are being run at present. Indeed, MHRA also plans to tweak the guidances again from questions arising from the various webinars.

A link to the area of interest with the above and other links can be found here https://lnkd.in/gwiGBAZ

CMDh updates – October 2020

• Revised best practice guides for the processing of Type IA and Type IB notifications in the mutual recognition procedure (tracked).

• Revised examples for acceptable and not acceptable groupings for MRP/DCP products document (tracked). A new example of variations involving changes to related substances specifications that are acceptable as single changes rather than as a grouping is included.

• Revised Q&A – Pharmacovigilance Legislation (tracked). Question “2. How should I submit a new RMP or an updated RMP to update my dossier?” has been updated.

• Revision 3 of the EU ASMF number request form, as well as contact points for submitting the request.

Last week’s round-up;
13-17 July 2020

New EMA opinion on nitrosamines

The CHMP has finalised its opinion on the presences of nitrosamines in human medicines, which is available on the EMA’s nitrosamine impurities website. The opinion requires pharmaceutical companies to take measures in order to limit as much as possible the presence of nitrosamines in their drug products and to ensure that the levels of these impurities do not exceed set limits. Such measures include the implementation of appropriate control strategies to prevent or limit the presence of nitrosamines as well as the improvement of manufacturing processes, where necessary. Companies will also be required to carry out the necessary risk assessments and evaluation and conduct appropriate tests if the risk of nitrosamine contamination is identified.

EU Notified Bodies designated under the EU MDR (2017/745)

There are currently 15 Notified Bodies(NB) designated under MDR with GMED France being the latest NB to be designated and also the first NB to receive designation in France. A full list of NB’s currently designated are listed below and on the Nando Database linked here https://bit.ly/39aaypy.

Manufacturers don’t know for certain if and when their NB will be designated and are advised to regularly check the Nando database to see status of NBs designate.

CMDh updates

The CMDh has revised the following documents (available with tracked changes): • Flow chart of the Decentralised Procedure. • CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures. • CMDh Best Practice Guide on Multilingual Packaging. CMDh has also published its Procedural guidance during Covid-19 pandemic, which includes a new template for notification of implementation of a change under a previously agreed ECMP.

MHRA COVID-19 Flexibilities

MHRA is offering to provide temporary inspection flexibility for manufacturers of human plasma-derived medicines, in exceptional circumstances. For 3rd country plasma collection sites that have been previously inspected by MHRA, they will implement a control measure in line with EMA recommendations and a Statement of Next Inspection (SONI) will be issued. For 3rd country sites that have not been previously inspected, MHRA gives 2 separate options depending on whether a partent company has been previously inspected or not. Full details of the guidance and all the MHRA COVID-19 Flexibilities can be found here: https://lnkd.in/dduB8EB

EDQM evaluation of impurity found in paracetamol API

The EDQM is actively working with a pharmaceutical company and other stakeholders to evaluate the detection of 4-chloroaniline, a carcinogenic impurity found in the active substance paracetamol that is manufactured by the company. The company concerned holds a Certificate of Suitability (CEP) for this active substance. The evaluation is underway to better understand the potential impact of this impurity as well as the extent of the issue.

Brexit: Joint technical notice by the European Commission, EMA and HMA

EC, EMA and HMA have announced that, since ‘The Withdrawal Agreement’ provides for a transition period end 31st Dec 2020 and no extension was requested as of 1st July 2020, there is no possibility of further extension beyond that date. Sponsors of EU CTs are reminded of the legal situation applicable after the end of the transition. Two specified areas that must be implemented prior to end of transition period are as follows; EU based QP will be required for IMP release and the sponsor or legal representative for the trial must be established within the EU. Further discussion can be found here: https://lnkd.in/dd2XgPt

New metformin recalls

Following last month’s voluntary recall of extended-release (ER) metformin by five pharmaceutical companies from the US market, the FDA has announced that another two manufacturers have issued further recalls of ER-metformin due to the presence of elevated levels of the potential carcinogen NDMA. Six pharmaceutical companies have been affected by the voluntary recalls. The FDA has also published a paper on the investigations carried out to study the initial discrepancies between FDA testing and testing by a private laboratory. The private laboratory, which had filed a Citizen Petition, reported higher NDMA levels in more metformin products than the FDA test results. On investigation, the cause of the discrepancy was found to be the presence of another chemical, N,N-dimethylformamide (DMF), that interfered with NDMA mass spectrometry measurements in the analytical methods used by the FDA. Further information on the latest ER-metformin recalls may be found here: https://bit.ly/RealCMC-3fogQ7n

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.

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.

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.

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.

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.

Last week’s round-up;
08 – 12 June 2020

PREVENTING AND REMOVING DISINFECTANT RESIDUES

Disinfectant residues can pose various risks to a cleanroom environment, and there is renewed focus on best practice related to their prevention and removal. Current industry thinking is that any residual chemical is a potential contaminant to a process and possibly to product, and regulators are showing increased concern over residual disinfectants. This article gives an overview on why these residues matter, their main sources, and how to assess related risks. It also explains ways to tackle these residues, including through a routine residue removal program, instituting “low-residue” disinfectant formulations, and focusing on operator training to control application: https://bit.ly/RealCMC-2C3DzqB

EMAs SME OFFICE HAS ISSUED THEIR 2019 ANNUAL REPORT

The EMA’s SME office has just issued their annual report for 2019. It makes for interesting reading. Some of the highlights include the highest ever number of registered SMEs with 12% created over the last 3 years. Product pipelines include 27% Orphan Medicines, 10% advanced therapies, 12% paediatric medicines and 25% generic medicines. Noteworthy too is the number of positive PRIME eligibility recommendations of 7 out of 16.

NEW EMA GUIDANCE: COVID-19 REMOTE GCP INSPECTIONS

The EMA has just issued new guidance on remote GCP inspections during the COVID19 pandemic. The inspection team, in agreement with the CHMP requesting the inspection, should make a case-by case decision on whether a remote inspection is considered appropriate and feasible. It too is assumed that Sponsors, CROs and service providers (e.g. medical imaging, central laboratories) have at their disposal advanced technologies, electronic systems and virtual working environments which facilitate remote staff or company locations worldwide to communicate systematically. These technologies may allow the necessary access for inspectors to the relevant systems (e.g. electronic trial master file (eTMF)) remotely and enable appropriate communication settings during inspection. The guidance covers initiation, preparation (setting, team location, technical requirements, agenda), conduct and reporting process.

EMA Q&A ON PROPORTIONALITY IN MULTIPLE STRENGTHS OF FIXED COMBINATIONS

The EMA has published a new ‘Clinical pharmacology and pharmacokinetics Q&A’ regarding biowaivers (Q&A 6.4) in fixed combination oral solid dosage forms. The EMA Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) allows for a biowaiver in multiple strength applications of fixed combinations as long as the applicant can demonstrate quantitative proportionality between the strengths. However, deviations from the quantitatively proportional composition are still considered acceptable under certain conditions. This extremely useful new Q&A provides clarification on these conditions and it also includes various examples.

EMA ISSUES A LEAFLET OUTLINING FAST TRACK PROCEDURES FOR COVID-19 TREATMENTS AND VACCINES

EMA has just issued a neat 1-page leaflet describing their preparedness to support the development and marketing authorisation of safe, effective and high-quality therapeutics and vaccines against COVID-19. The Agency has put in place rapid review procedures related to COVID-19 to deliver assessments of high-quality applications from sponsors in the shortest possible timeframes.

EMA REGULATORY SCIENCE STRATEGY TO 2025 PUBLISHED ON THE NATURE SITE

This morning I was reading a very interesting commentary on the EMA Regulatory Science strategy to 2025 published on the Nature site. The article spoke to the core recommendations that stakeholders deem the most significant to advance evidence generation for medicines, including fostering innovation in clinical trials, reinforcing patient relevance in evidence generation, use of high quality real-world data in decision making, developing the regulatory framework for emerging data sources and contributing to HTAs’ preparedness and downstream decision-making for innovative medicines.

PIC/S ADOPTS NEW CROSS-CONTAMINATION AND HBEL GUIDANCE

As of June 1st 2020, two new Pharmaceutical Inspection Co-Operation Scheme (PIC/S) guidance documents have entered into force: Questions and Answers on Implementation of Risk-based Prevention of Cross-contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’, and an aide-memoire on health-based exposure limit (HBEL) assessments. The Q&A guidance on cross-contamination fully mirrors the EMA’s guideline of the same name except for an additional references section that points to other PIC/S guidelines. Whereas the HBEL guidance document “describes an approach to assessing HBEL that can be conducted by inspectors without specialised toxicology knowledge”.

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

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

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; 23 – 27 March 2020

EMA NEWS: ONGOING CLINICAL TRIALS AND RISK EVALUATION FOR NITROSAMINE IMPURITIES

The EMA has published a “points to consider” document on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials for comment. https://lnkd.in/g9PYa_e

The European medicines regulatory network has agreed to extend the deadline to complete step 1 risk evaluation of all human medicines containing chemically synthesized active substances for the presence of Nitrosamines to 1 October 2020. This decision follows reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic.
https://lnkd.in/g8TVSwk

EUROPEAN COMMISSION (EC) – PROPOSE ONE-YEAR POSTPONEMENT OF MDR IMPLEMENTATION

The EC has announced that because of COVID-19 crisis, work is ongoing on a proposal to postpone the date of application of the MDR for one year to May 2021. The EC are working to submit this proposal in early April and have called on Parliament and Council to adopt it quickly as the deadline for entry into force is the end of May 2020.

The proposed postponement if adopted will provide much relief to the medical device sector amidst this ongoing crisis. The announcement from the Commission can be viewed here https://lnkd.in/dTw3NDR

EC ISSUES A TARGETED STAKEHOLDERS’ CONSULTATION ON ANNEX 21: IMPORTATION OF MEDICAL PRODUCTS, OF THE EUDRALEX VOLUME 4

In addition to the guidance given in the main chapters and annexes of the EU GMP it has become necessary to publish a specific guideline clarifying the application of the principles of GMP in the activity of importation of medicinal products under Annex 21. This Annex sets out the good practice applicable to a manufacturing and importation authorisation (MIA) holders, who import medicinal products (human and veterinary) through the EU/EEA borders. The comments received will be taken into account by the European Commission in the finalisation of the Guideline. It will run from 20th March 2020 through to and including 20th June 2020. All stakeholders are invited to respond to the draft guidance here https://lnkd.in/dgyWg3E and to use the template for responses here https://lnkd.in/drgVsqK. The format and email for responses are also detailed on the site.

EMA NEW GUIDANCE: GUIDANCE ON PAEDIATRIC SUBMISSIONS VIA ESUBMISSION GATEWAY AND ESUBMISSION WEB CLIENT

EMA has issued a short practical guidance on making submissions for paediatric investigation plans and waivers via the eSubmission Gateway and the eSubmission web client platforms. The guidance states that a letter of intent for PIPs and PIP waivers is no longer required, it includes a full listing of documents required by submission type and a very good tabulation on naming conventions for each of the files comprising the submission.
The new guidance can be found here https://lnkd.in/giT5HjD and there are further links therein to other specific supportive documents.

TIME TO FOCUS ON WHAT WE CAN WORK TOGETHER ON

We have the team and skillsets to help you with these activities. We are all ready and available to do so. Please see our website for further details of our services, www.realregulatory.com

NICE UPDATE: FREE FAST TRACK ADVICE FOR COMPANIES WHO ARE DEVELOPING DIAGNOSTICS OR THERAPEUTICS FOR COVID-19

NICE Scientific Advice will provide free fast track advice for companies who are developing novel diagnostics or therapeutics for COVID-19.

The fast track service will help companies optimise their approach to generating essential levels of evidence required for health technology assessment. Depending on the demand for the free advice service, NICE may need to prioritise requests.
All scientific advice services will continue to run as normal, with meetings taking place virtually for the foreseeable future. Developers are invited to get in touch via our online form with enquiries about any of their services. https://lnkd.in/d48KfmC

CMDH UPDATE TO Q&A ON BIOLOGICALS

CMDh has just updated their Q&A on Biologicals, full details can be found under this link https://lnkd.in/dAjYHw5
Apart from generally updating reference legislation, in section 3 detailing special requirements for biological products an important bullet point on the legal basis has changed.

The legal basis for MAs as bibliographic applications according to Article 10a of Directive 2001/83/EC are now ‘strongly discouraged’. It is also further stressed that ‘It is highly recommended to ask the RMS for scientific and regulatory advice on the most appropriate legal basis’.

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.

Real Regulatory is now part of tranScrip – your life science powerhouse.

In March 2022, Real Regulatory became a subsidiary of tranScrip, a leading contract drug development organisation supporting the entire life cycle of medicines.

As a result, this website is now closed. You can now keep up-to-date with us at www.transcrip-group.com

This is a really exciting journey for both companies and we look forward to working with you on your development programmes, from discovery through to post-licensing.

Thank you.

Last week’s round -up; 01-05 February 2021

Pharmeuropa updates

EMA News: EMA announces detail approach on training for the new Clinical Trial Regulation CTIS portal.

EMA News: EMA has issued a new draft guidance on the Module 3 quality support packages required for MAAs of PRIME Designated Medicines.

EMA News: EMA has published detailed accelerated assessment timetables for ATMP full MAAs

UK MHRA updates Pharmacovigilance System requirements

UK MHRA publishes the submission dates for the new UK national MAA 150-day procedures

Updates from the EDQM

Last week’s round-up; 26 – 30 October 2020

New FDA Guidance on Referencing Approved Drug Products in ANDA Submissions

EMA’s implementation plan to address nitrosamine impurities

EMA issues a reflection paper on development of Medicines for use in older populations

MHRA UK and EU Transition: new rules for 2021

CMDh updates – October 2020

Last week’s round-up; 13-17 July 2020

New EMA opinion on nitrosamines

EU Notified Bodies designated under the EU MDR (2017/745)

CMDh updates

MHRA COVID-19 Flexibilities

EDQM evaluation of impurity found in paracetamol API

Brexit: Joint technical notice by the European Commission, EMA and HMA

New metformin recalls

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

Ph.Eur. Supplement 10.3

New EMA Bioequivalence Guidance for Levothyroxine Tablets and Abiraterone Tablets

EMA, EC and Health Canada Confidentiality Arrangement

FDA testing methods to detect nitrosamine impurities in Metformin

Global regulators work towards alignment

EDQM companion list of training materials for vaccines

EMA and HMA news: Mandate of the European Innovation Network

Last week’s round-up; 08 – 12 June 2020

PREVENTING AND REMOVING DISINFECTANT RESIDUES

EMAs SME OFFICE HAS ISSUED THEIR 2019 ANNUAL REPORT

NEW EMA GUIDANCE: COVID-19 REMOTE GCP INSPECTIONS

EMA Q&A ON PROPORTIONALITY IN MULTIPLE STRENGTHS OF FIXED COMBINATIONS

EMA ISSUES A LEAFLET OUTLINING FAST TRACK PROCEDURES FOR COVID-19 TREATMENTS AND VACCINES

EMA REGULATORY SCIENCE STRATEGY TO 2025 PUBLISHED ON THE NATURE SITE

PIC/S ADOPTS NEW CROSS-CONTAMINATION AND HBEL GUIDANCE

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

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

AMENDING THE DETAILS OF AN EU ORPHAN DRUG DESIGNATION SPONSOR

MCDG GUIDANCE ON MDR CLINICAL INVESTIGATIONS AND EVALUATIONS

EC: MITIGATING CLINICAL TRIAL DISRUPTION IN EUROPE

MDR POSTPONED BY ONE YEAR

Last weeks round-up; 23 – 27 March 2020

EMA NEWS: ONGOING CLINICAL TRIALS AND RISK EVALUATION FOR NITROSAMINE IMPURITIES

EUROPEAN COMMISSION (EC) – PROPOSE ONE-YEAR POSTPONEMENT OF MDR IMPLEMENTATION

EC ISSUES A TARGETED STAKEHOLDERS’ CONSULTATION ON ANNEX 21: IMPORTATION OF MEDICAL PRODUCTS, OF THE EUDRALEX VOLUME 4

EMA NEW GUIDANCE: GUIDANCE ON PAEDIATRIC SUBMISSIONS VIA ESUBMISSION GATEWAY AND ESUBMISSION WEB CLIENT

TIME TO FOCUS ON WHAT WE CAN WORK TOGETHER ON

NICE UPDATE: FREE FAST TRACK ADVICE FOR COMPANIES WHO ARE DEVELOPING DIAGNOSTICS OR THERAPEUTICS FOR COVID-19

CMDH UPDATE TO Q&A ON BIOLOGICALS

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

FINAL VERSION OF ICH GUIDELINE Q12 HAS BEEN PUBLISHED

EMA NEWS: QUALIFICATION OF NOVEL METHODOLOGIES FOR MEDICINE DEVELOPMENT

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

EMA ISSUES A PRESS RELEASE ON RECENT ORGANISATIONAL CHANGES

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