The European Medicines Agency had announced a guideline on GCP for ATMPs. Now, the Draft Guideline on Good Clinical Practice for Advanced Therapy Medicinal Products has been published and is open for targeted stakeholder consultation unti end of October.
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.
As concequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".
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The FDA recently finalized its October 2017 draft guidance on how to handle amendments to generics submissions by publishing the final guidance ANDA Submissions – Amendments to Abbreviated New Drug Applications Under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.
The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.
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After considering public comments FDA received about the draft guidance on “Statistical Approaches to Evaluate Analytical Similarity” issued in September 2017 the agency decided to withdrew the proposal.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.