AIFA communication on the management of reports of lack of efficacy in the National Pharmacovigilance Network

The Italian Medicines Agency (AIFA), in line with what is written in Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) and in the Ministerial Decree April 30, 2015, intends to provide details on the management within the National Pharmacovigilance Network (RNF) of the reports of suspected adverse reactions related to lack of efficacy.
May 13, 2021

EMA regulatory update for Signal Detection May 2021

EMA recently released draft agenda for “Pharmacovigilance Risk Assessment Committee (PRAC)” meeting conducted in between 03 May 2021 to 06 May 2021 for the assessment of new signals detected from new sources. Assessment for important items are from Item no. 02 to Item no. 09.
May 7, 2021

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

Since 1 January 2021, new marketing authorisation applications for such products submitted in the European Union must comply with these requirements and all veterinary medicinal products will have to comply by January 2023. The European Pharmacopoeia is proposing to delete the cross-references to the test for Heavy Metals (HMs, general chapter 2.4.8) in the 16 monographs on substances “for veterinary use only”.
May 5, 2021

List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs) (XLS/2 MB) (updated)

EMA released updated “List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)” on April 28, 2021. EMA updates the EURD list every month, following adoption by the Committee for Medicinal Products for Human Use (CHMP) and Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), after consultation with the Pharmacovigilance Risk Assessment Committee (PRAC).
April 29, 2021

Factsheet for Class I Medical Devices

What you need to know about Regulation (EU) 2017/745? This factsheet is aimed at manufacturers of Class I medical devices. It covers devices that have already been placed on the market under Directive 93/42/EEC (MDD) and new devices intended to be placed on the market for the first time in accordance with Regulation (EU) 2017/745 of the European Parliament and the Council of 5 April 2017 (MDR).
April 29, 2021


The concept of similarity in an ATMP setting has been updated by European Commission on April 13. The Q&A document has been revised with new questions and examples based on accumulated experience. In particular, these questions have been raised by developers of ATMPs regarding the application of the concept of “similar active substance” in ATMP setting:

  1. What differences in the starting materials may be considered relevant to support a claim of non-similarity?
  2. Can a difference in principal molecular structural features be considered relevant to support a claim of non-similarity?
  3. What level of evidence should be provided to demonstrate that differences in the biological characteristics and/or biological activity are relevant for the intended therapeutic effect and/or safety attributes of the product?

April 29, 2021

EU clinical trial portal and database declared functional

The European Medicines Agency (EMA) announced that the clinical trial EU Portal and Database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation by 31 January 2022. (The CTIS was originally expected in September 2018 but a series of delays have pushed back the launch). “The implementation of the Clinical Trial Regulation and CTIS will increase efficiency in the registration, conduct and supervision of clinical trials in the EU, particularly those taking place in multiple Member States, while ensuring utmost transparency for the public. This is one of the most complex and ambitious IT developments carried out by EMA…” said Christa Wirthumer-Hoche, chair of EMA’s Management Board.
April 22, 2021


Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects.
April 16, 2021