Last weeks round-up; 28 October – 1 November 2019

MHRA GMDP SYMPOSIUM 11-12 November 2019

We’re excited to be discussing the latest updates on guidance and increasing complexity in the manufacturing and distribution chain requirements with our peers at the MHRA GMP & GDP Symposium in London, 11-12 Nov. If you’re also attending, get in touch! Our QMS and regulatory affairs compliance expert Niamh Miller would love to see you there! Contact us to arrange a meeting: https://lnkd.in/daQjxxj

RECOMMENDATIONS ON SUBMISSION DATES IN 2020 FOR DCP AND MRP Procedures

HMA-CMDh has just issued their annual recommendation on submissions dates for DCP and MRP for 2020. Check out the individual links below for details ⬇️⬇️

Recommendations on submission dates in 2020 for applicants of the DCP: https://www.hma.eu/92.html

Recommendations on submission dates in 2020 for applicants of the MRP: https://www.hma.eu/93.html

EMA ISSUES NITROSAMINE IMPURITIES OVERVIEW

EMA has issued an overview to advise companies on steps to take to avoid nitrosamines in human medicines. This includes templates, published 28th Oct 2019, for responses to EMA following Step 1: Risk evaluation and Step 2: Perform further confirmatory testing. Further details can be found on the EMA website here: https://lnkd.in/d9T22zp

EUROPEAN COMMISSION: GMO REQUIREMENTS FOR ATMPS IN CLINICAL TRIALS

A Good Practice document on the assessment of GMO related aspects in clinical trials with AAV clinical vectors has been developed by the national competent authorities & the Commission services. It builds on possibilities under the existing legislation to facilitate the conduct of clinical trials with ATMPS and has been endorsed by Austria, Belgium, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Luxembourg, Netherlands, Portugal, Romania & Spain.

Developers that intend to conduct a trial in these countries can follow the approach laid down here: https://lnkd.in/ey2NfV9

In addition, a common application form for investigational medicinal products for human use that contain or consist of AAV vectors has been endorsed by the above Member States: https://lnkd.in/eCmCCEE

EMA DIALOGUE WITH CHINESE AUTHORITIES ON MEDICINES REGULATION

The Deputy Commissioner of the Chinese National Medical Product Administration (NMPA) visited EMA on 25 October together with a delegation. The visit took place in the context of the ongoing EU-China regulatory dialogue on pharmaceuticals. Topics for discussion included GMP standards for active pharmaceutical ingredients, GCP standards, and the Commission’s strategic approach to pharmaceuticals in the environment. Further discussion can be found here https://lnkd.in/eYr5dBK

 

Last weeks round-up; 14 – 18 October 2019

EVALUATION OF THE EU BLOOD, TISSUE AND CELLS LEGISLATION

On 11 October 2019, the European Commission published its evaluation of the EU blood, tissues and cells legislation. An executive summary is also available. This was the first evaluation of the legislation since the adoption of the basic Acts in 2002 (blood) and 2004 (tissues and cells). Further information and a link to the evaluation can be found under this link https://lnkd.in/ds48XHY. The results of the evaluation will be disseminated at a Conference in Brussels on 28 October 2019.

EMA: UPDATED VERSIONS OF eAFs NOW AVAILABLE

EMA has just issued version 1.23.1.3 of the 4 electronic Application Forms (eAF), which are now available on the eAF website, along with new release notes and a release milestone plan. This release is a bug fix release to correct a number of issues which affect the forms. The bug fix release does not affect the Data Exchange Standard (DES). Applicants are reminded that the version of the form should not be changed during an ongoing procedure. https://lnkd.in/de7AFKu

PAEDIATRIC COMMITTEE (PDCO) MEETING MINUTES

An overview of Pedmed-NL (the former Dutch Medicines for Children Research Network) was presented. The network has been involved in the development of the Dutch Paediatric Formulary (kinderformularium), the establishment of European Paediatric Translational Research Infrastructure (EPTRI) and Paediatric Clinical Research Infrastructure (PEDCRIN) as well as in the planning of clinical trials, mainly via Connect4Children (C4C). The network was relaunched in 2018 as PedmedNL with main goal to facilitate and support the conduct of C4C proof of viability studies (by 2023). The main goal beyond 2023 is to create a sustainable network for research in children. The minutes can be found under; https://lnkd.in/dpNCPqQ

UK WITHDRAWAL FROM EU: EMA RELOCATION TO AMSTERDAM

EMA has recently reported a further 6% reduction in workforce as a result of relocating to Amsterdam. As a result EMA is reviewing its organisational structure and looking to set up task forces that will focus on key priorities for the European medicines regulatory network further details can be found here: https://lnkd.in/dx49VpY

EMA ADVISES COMPANIES ON STEPS TO TAKE TO AVOID NITROSAMINES IN HUMAN MEDICINES *UPDATE*

As previously advised, EMA has requested all EU marketing authorisation holders of medicinal products containing chemically synthesised APIs to review their medicines within the next 6 months for the presence of nitrosamines. Real Regulatory has both the expertise and resource to support this review process. For more information on the EMA recommendation, including a Q&A quide: https://lnkd.in/erne7TZ

EMA PRIME ELIGIBILITY REQUESTS

EMA has just published its deadlines and timetable for PRIME Eligibility request assessments for 2020. Further details can be found here; https://lnkd.in/d7Z8x6J