GMP NEWS 2018

GCP for ATMP - Stakeholder Consultation on the Draft Guideline

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.

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The increasing Importance of Gene Therapies - FDA Statement and New Guidelines

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.

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European Commission publishes revised Version of EU GMP Guideline Annex 2

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".

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What information is included in a CEP?

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.

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FDA criticises missing stage 3 in validation lifecycle

In a five-page warning letter to an OTC manufacturer, the US Food and Drug Administration (FDA) criticises, inter alia, the missing program for continued  process verification.

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How should modern analytical development be conducted?

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.

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Generics: FDA´s final Guidance for Handling Amendments to Submissions

The FDA recently finalized its October 2017 draft guidance on how to handle amendments to generics submissions by publishing the final guidance ANDA Submissions – Amendments to Abbreviated New Drug Applications Under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

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Brexit: EMA updates information for holders of centralized marketing authorizations

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

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What makes a good RP?

In its blog the Medicines and Healthcare products Regulatory Agency (MHRA) explains what the UK authority expects from a Responsible Person: knowledge, experience, training.

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No Monitoring needed if there are no Storage Conditions on the Outer Packaging?

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.

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PIC/S implements EU-GDP for APIs

PIC/S adopt EU GDP principles of GDP for active substances for PIC/S purposes.

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Import vs. Manufacturing: Any Differences in the EU?

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?

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Cooperation of international authorities for inspecting API manufacturers

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.

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What are the Differences between EU and FDA GMP?

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".

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ICH M11: CeSHarP

In June 2018 the ICH Assembly agreed to work on a new guideline ICH M11 "Clinical electronic Structured Harmonized Protocol (CeSHarP)".

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Similarity by Design: FDA Withdraws Draft Guidance on Statistical Approaches

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.

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Collecting Patient Experience Data for Product Development

The FDA recently released a guidance on patient experience data from patients, caregivers, clinicians and others for product development and regulatory decision-making.

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ICH M9 Guideline on BCS-based Biowaivers

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

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Valsartan: what caused the contamination?

There are currently massive problems with Valsartan preparations due to contamination of the active substance. But where is it coming from? And could it have been prevented?

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United Kingdom wants to remain a member of EMA

It's official: the United Kingdom wants to remain in the EMA. This can be gathered from a recent statement by the government.

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