GMP NEWS 2018

The increasing importance of Gene Therapy becomes obvious when you take a look at the increasing focus of the competent authorities - as, for example, the current FDA's six new guidance documents on Gene Therapies show.

The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.

The board of the ECA Foundation's "Analytical Quality Control Group" wants to strengthen the lifecycle approach to analytical development. Therefore, the Group developed a new guideline on "Analytical Procedure Lifecycle Management". Find out more about the content of the new APLM Guideline and on how modern analytical development should be conducted today.

The European Medicines Agency (EMA) has published updated versions of the documents provided to help marketing authorization holders prepare for Brexit.

The question on monitoring requirements for packaging with no storage condition information was the first GDP-related question being published along with an answer in the Q&A Section of EMA's website.

What does it mean that, in the European Union (EU), all of the requirements for and obligations of Manufacturing Authorisation holders (MIAHs) also apply to importers?

While EU and FDA GMP Guidance is very similar, there are also some areas where there are known differences. It is worthwhile being aware of these differences when dealing with companies and authorities from the "other side".

After considering public comments FDA received about the draft guidance on “Statistical Approaches to Evaluate Analytical Similarity” issued in September 2017 the agency decided to withdrew the proposal.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.

The ICH M9 Guideline has reached the consultation step. The Guideline is proposed to address Biopharmaceutics Classification System (BCS)-based biowaivers.