Last week’s round -up;
25-29 October 2021
Antimicrobial Resistance – expected regulatory implications
Activities of the Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) are expected to have regulatory implications. Mentioned within their current progress report are agreements on clinical trial recommendations that will be reflected in updated guidance documents for several different types of bacterial diseases. Also identified for continued collaboration up till 2026 are strategies to improve financial incentives, access, research, and development of antimicrobial drugs, diagnostics, and alternatives. Furthermore, the definitions for multidrug-resistant (MDR), extensively drug-resistant (XDR) and pan-drug-resistant (PDR) bacteria for human infections will be revised.
https://lnkd.in/euK-FM_f
Japan’s PMDA posts English translation of guidelines for bioequivalence studies
Japan’s PMDA has released an English translation of guidelines and questions and answers on bioequivalence studies of generic products.The guidelines cover bioequivalence studies, dissolution tests and other assessments for various dosage forms, including oral immediate release and oral extended-release products. The guideline also features a shorter section on non-oral dosage forms and dosage forms for which bioequivalence studies are waived.
https://bit.ly/RealCMC-3EsokCu
Guidance on good lay summary practice
Guidance on good lay summary practice (GLSP) has recently been published by the European Commission. The guidance provides recommendations on how to prepare, write, translate, and disseminate summaries of clinical trial results in lay language, and was adopted by the expert group on clinical trials in July 2021. Sponsors should note that lay summaries on each clinical trial are a mandatory requirement of the upcoming Clinical Trial Regulation. Relatedly, the guidance highlights mandatory requirements under the regulation, and those which are optional recommendations based on ethical obligations and related best practices.
https://lnkd.in/dzJMMANW
Updates from the EDQM
The EDQM has released the following updates:
• A revised osmolality chapter for public comment in Pharmeuropa. The revised chapter focuses on osmolality reference solutions using sodium chloride that are required for instrument verification. The deadline for comments is the 31st December 2021.
• The Pharmacopoeial Discussion Group is preparing a pilot for global expansion of membership to integrate additional world pharmacopoeias.
• CEP holders are invited to comment on draft monographs published in Pharmeuropa 33.4. The deadline for comments is 31st December 2021.
• CEP holders are invited to update their applications according to the revised monographs published in Ph. Eur. Supplement 10.7 that will be implemented on the 1st April 2022.
https://bit.ly/RealCMC-3nTq1lN
Public consultation on EU pharmaceutical legislation
The European Commission has launched a public consultation on the revision of the EU’s pharmaceutical legislation. The consultation will last until 21st December 2021 and will gather views from stakeholders and the general public. The last review of the EU’s pharmaceutical legislation took place almost 20 years ago and the overarching aims of this revision are: to ensure access to affordable medicines, foster innovation, improve security of supply, adapt to new scientific and technological developments, and reduce red tape. In the consultation, the EC also asks if there are other problems it needs to address.
https://lnkd.in/d6snDbtU
The EMA’s tailored scientific advice offering for biosimilar development will be continued
In its report on the initial pilot offering of tailored scientific advice for new biosimilar development, the EMA has announced that this will be continued as part of regular scientific advice operations. When using the procedure, developers are advised on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available. The service will be capped at a maximum of 2 procedures per month, and the duration is set to 70 days if managed without a discussion meeting or 100 days if such a meeting is needed.
https://lnkd.in/eW6FtBem
Updated Q&A on GMP compliance for IMPs
The European Commission has released an updated Q&A no. 8.4 on the Clinical Trials Regulation 536/2014. The updated Q&A covers the documentation that is required to show compliance of an IMP and AxMP with GMP, which is also outlined in Chapter IX and Annex 1 section F of the CTR:
• No documentation is required for IMPs authorised in the EU (even if not manufactured in the EU).
• For IMPs that are not authorised in the EU and do not have an MA from a third country that is party to ICH, and are not manufactured in the EU, an authorisation referred to in article 61(1) and a QP declaration of GMP equivalence is required. In the latter case, if a Mutual Recognition Agreement (MRA) covering clinical trials is in place with the particular country, the latter declaration is not required if the MRA provides for GMP equivalence already.
• An authorisation according to article 61 of the Clinical trial Regulation is required for all other cases.
• Information regarding the GMP compliance of APIs is not required by the CTR (and can therefore not be required by the Member States concerned).
https://bit.ly/RealCMC-3GpA3n5
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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.
