GMP NEWS 2017

EMA updates Website on Mutual Recognition Agreements

The European Medicines Agency, EMA, has updated its page on Mutual Recognition Agreements (MRA). Read more about the Questions and answers on impact of EU-US mutual recognition agreement on marketing authorization applications and relevant variations.

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API starting materials - New Q&A document for ICH Q11

The recently published ICH question/answer document on starting materials specifies the regulations of the guideline ICH Q11. Read more about what is important in terms of the selection of starting materials and their justification and what data needs to be supplied in the marketing authorisation dossier.

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EMA Non-Compliance Report for Brazilian Manufacturer of sterile Products

During an inspection, the Italian regulatory agency found major deficiencies at the site of a Brazilian manufacturer of antibiotics. Read more about the EMA's Non-Compliance Report.

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How to become a QP in Europe

Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person.

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New ICH E9 Addendum reaches Step 2b of the ICH Process

The International Council for Harmonisation (ICH) recently published its proposed E9 Addendum to define the appropriate estimand for a clinical trial. Read more about the draft E9(R1) Addendum: Statistical Principles for Clinical Trials.

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QbD: New EMA Guideline on Manufacture of the finished Dosage Form

The EMA published its new Guideline on Manufacture of the finished dosage form. The new EU guidance will help applicants in preparing marketing authorization dossiers and in what to include in Module 3 of their common technical document.

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Safety by Design: EMA Reflection Paper on Development of Medicines for Use in the older Population

The EMA recently published a draft Reflection Paper on the pharmaceutical development of medicines for use in the older population.

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EU-US MRA: New Commitment

There is a new commitment between EC, EMA and FDA allowing to share full inspection reports between agencies.

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Test for Subvisible Particles: ICH Harmonisation Completed

With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed. Read more about Tests for Subvisible Particles.

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FDA publishes Draft Guidance for Medical Gases

Recently, the FDA published a new Guidance for Industry draft document. It is intended to help medical gas manufacturers introduce and implement GMP regulations. Read more about GMP requirements for medical gases.

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FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms

The FDA is proposing a more restrictive expiration dating for unit-dose repackaged solid oral dosage forms. Read more about FDA´s draft guidance Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.

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ECA Validation Group - Update on Activities

The ECA Validation Group was established with the goal to gather knowledge on validation, for example by continuously developing a Process Validation Good Practice Guide. Find out more about what is new in the ECA Validation Group.

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Brexit: the British comment

After the European Medicines Agency EMA in particular spoke out on the possible future of the trade with medicinal products on European Union level, the British now provide some input - e.g.. about the role of the Qualified Person (QP). Read how the Britisch imagine the trade with medicinal products in the future.

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EMA publishes final Version of Q&A Paper on Production of "cold" WFI

After the change to the European Pharmacopoeia, it is possible to produce water for injection by other methods than distillation since April 1st 2017. The European Medicines Agency (EMA) published a Q&A draft document in 2016 as an additional guideline. These Questions & Answers on WFI have now been published in its final version.

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ICH announces new E19 Guideline on Optimization of Safety Data Collection

The ICH E19 Concept Paper and Business Plan have been released. Read more about the E19 Concept Paper on Optimization of Safety Data Collection.

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FDA & EMA´s collaborative Clinical Trials Approach for rare Diseases

The European Medicines Agency (EMA) recently published a collaborative clinical trials approach together with the FDA for rare paediatric diseases. Read more about the joint proposal "Paediatric Gaucher disease - A strategic collaborative approch from EMA and FDA".

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Revised Ph. Eur. Chapter Tablets

Recently, the revised Ph. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. Read more about the revised monograph on the dosage form Tablets.

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Inspectorate clarifies Responsibilities and Duties of the IMP QP

In the manufacturing and release of IMPs, not all requirements of Annex 16 can be transferred one to one. MHRA is now trying to clarify the most important questions.

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New questions and answers about safety features - Version 7 of the EU Q&As published

The soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017. Find out more about the revised Q&A document of the EU about safety features.

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EMA non-compliance report on Brazilian manufacturer of sterile medicinal products

During an inspection, the french authorities found major deficiencies at the site of a Brazilian manufacturer of sterile medicinal products. Learn more details about the EMA's non-compliance report.

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