News

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

published 4 Nov 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