GMP News - Regulatory Affairs

The FDA recently finalized its October 2017 draft guidance on how to handle amendments to generics submissions by publishing the final guidance ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA.

After considering public comments FDA received about the draft guidance on “Statistical Approaches to Evaluate Analytical Similarity” issued in September 2017 the agency decided to withdrew the proposal. The guidance was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.

ICH Q12, currently in draft form for public consultation, provides an opportunity to save time and money associated with regulatory submissions. Read more about "new" lifecycle tools and enablers for global post-approval change management provided in the proposed guideline on "Life Cycle Management".

The revised Annex 17 of the EU GMP Guide has been publised and will come into operation on 26 December 2018. Read more about the guideline on Real Time Release Testing and Parametric Release.

The European Medicines Agency (EMA) has published two updated documents on U.K.´s withdrawal from the EU - giving a lot of new Questions and Answers on Brexit.

The UK Government recently confirmed that it is committed to implementing the EU CTR into UK law to the extent possible after Brexit.

QRM is becoming more and more appreciated and implemented through guidance like the EU-GMP Guidelines and ICH Q8 - Q12. And Quality Risk Management is much more than merely FMEA.