Last week’s round-up, 11 -15 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud

ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

15 November 2019

A recent survey shows wide adoption of ICH guidelines across regulators and industry.

The survey collected responses from 32 pharmaceutical companies who provided information on 15 regulatory authorities, which ranged between ICH founding members, newcomers and observers. There was generally strong evidence of guideline implementation and adherence across the authorities, and company perceptions were in line with authority self-declarations for the majority of guidelines.

ICH guidelines were mostly implemented without modification in the various countries sampled, with the highest proportion of modifications being present in observer countries. ICH founding members implemented the fewest modifications: http://bit.ly/RealGenerics-2NQNYZY

Getting in Touch with New Guidance on Topical Products

14 November 2019

Regulations related to generic topical products are changing, and this is expected to lead to an increase in related market approvals in Europe and the US.

Barriers that dissuade companies from investing in the product development required are being recognized by regulators and steps are being taken to encourage more topical generic product development. These are reviewed in the following article, which also outlines recent precedent set by the MHRA and EMA in approving two topical applications for generic products without supporting clinical bioequivalence data: http://bit.ly/RealGenerics-353v2wG

EC Offers Further Clarity on Clinical Trial Regulation

13 November 2019

A new and revised Q&A on the incoming Clinical Trials Regulation has recently been published by the European Commission.

The new Q&A deals with requests for information, how assessment reports will be made public, and the sponsor’s responsibilities relating to non-substantial amendments. In terms of the latter, where such changes are relevant to the supervision of the trial, sponsors will be expected to update the EU database.

The revised Q&A relates to the definition of a ‘medicinal product’ in relation to clinical trials, endpoints that need to be included within the lay summary of results of a clinical trial, and procedures relating to submission of Part II of the clinical trial application for applications which were previously limited to Part I. Under the new Clinical Trials Regulation, Part I of the clinical trial application is jointly assessed by all member states concerned; part II is assessed by each member state separately: http://bit.ly/RealGenerics-2Kj0AH1

EU Regulatory Roundup: Ireland’s HPRA Tracks 4-Fold Increase in Marketing Authorization Transfers

12 November 2019

The impact of Brexit is evident in HPRA’s latest annual report.

Ireland’s HPRA has reported a 400% increase in its annual number of marketing authorisation holder (MAH) transfers. It has also taken the lead on 66% more EMA scientific advice projects than the previous year.

In other regulatory updates, the EMA has asked companies to file Type IA and Type IA(IN) variations for 2019 by 29 November. Swissmedic has also clarified its rules on making multiple changes in one Type II variation filing. Spain’s AEMPS has strongly criticised a recently released ICH guideline on the optimization of safety data collection: http://bit.ly/RealGenerics-32FvK1L

Announcement to all CEP holders for synthesised APIs regarding presence of nitrosamines

11 November 2019

An announcement to all CEP holders for synthesised APIs regarding the presence of nitrosamines has been published by the EDQM.

The announcement details the steps that all such CEP holders should take, namely: risk evaluation with regards to nitrosamine formation, followed by confirmatory testing and CEP revision where applicable. Any required revisions to CEP applications should be concluded by 26th September 2022 at the latest, and the EDQM has reminded CEP holders that they should provide the appropriate information to their customers to allow marketing authorisation holders to fulfil their related responsibilities.

EDQM notes that they may contact CEP holders for related information at any step in the review, and that action will be taken on any CEP where information becomes available regarding an unacceptable level of nitrosamine impurities in the active substance: http://bit.ly/RealGenerics-2Q4Vv8X

Image: laboratory equipment, Public Domain Mark 1.0