GMP News - Pharmaceutical Development / Clinical Trials / GCP

04.02.14

New EMA Guidance Qualification of novel Methodologies for Drug Development

The European Medicines Agency EMA has published the revised Guidance to Applicants "Qualification of novel methodologies for drug development". Read more.

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04.02.14

New FDA Guidance for Drug Development Tools

The FDA has published a new Guidance for Industry and FDA Staff: "Qualification Process for Drug Development Tools". Read more.

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04.02.14

Health Commissioner welcomes Agreement on the Revision of EU Rules on Clinical Trials

In a memo of the European Commission, Health Commissioner Tonio Borg welcomes the agreement on the revision of EU rules on Clinical Trials. Read more.

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04.02.14

GCP and Bioequivalence Studies: new FDA/EMA Initiative

The scope of the FDA/EMA initiative on GCP inspections will be expanded to include inspections for generic marketing applications. Read more.

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03.09.13

FDA: Import of Drugs prior to approval

The U.S. Food and Drug Administration FDA has issued a draft guidance to define how the agency intends to deal with requests to import unapproved drug products. Read more.

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03.09.13

Quality by Design: Lessons learnt from EMA/FDA Pilot Program

EMA and FDA published a joint report on the pilot program on Quality by Design (QbD) applications. Read more.

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03.09.13

EMA publishes Guideline on Pharmaceutical Development of Medicines for Paediatric Use

The European Medicines Agency has published the final Guideline on pharmaceutical development of medicines for paediatric use. The date for coming into effect is 15 February 2014. Read more.

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13.08.13

PLAIR - new FDA Guideline regulates Import of non-approved Drugs in the Run-Up to the Launch in US

Under certain circumstances unapproved bulk or finished products can be imported in the United States before granting the marketing authorisation. For this purpose the FDA recently described a new standardised approach in a draft of a "Guidance for Industry". What pharmaceutical companies have to consider prior to launching their products in the United States you can read here.

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01.08.13

New Requirements of the FDA on Stability Testing of Generic Drugs

The stability data required in an application for the authorisation of a generic medicinal product for the American market have been redefined in a new FDA Guideline. Read more here.

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01.08.13

Classification of Dosage Forms according to the USP

The USP divides the pharmaceutical dosage forms into 5 groups and wants to elaborate new General Chapters to depict the quality and performance requirements specific to each of these 5 dosage forms. The current status of implementation is addressed in an interesting article of the Pharmacopeial Forum. Read more.

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23.05.13

EU: New Q&A Document on Clinical Trials

Version 11.0 of the Questions & Answers Document in Eudralex Volume 10: Clinical Trials - Chapter V has been published. Read more.

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23.05.13

FDA Two new Q&As published for Investigational Drugs

The U.S. Food and Drug Administration FDA has published two new Question and Answer Documents on Investigational Drugs. Read more.

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23.05.13

QP Template for IMPs manufactured in third Countries

The EU Commission has published the final Template for the Qualified Person's Declaration of Equivalence to EU GMP for IMPs manufactured in third countries. It seems that they accepted some proposals made by stakeholders in their comments. Read more.

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06.03.13

ICH publishes New Draft Guideline on Genotoxic Impurities

A new ICH draft guideline on genotoxic impurities in APIs and medicinal products should help compensate shortcomings in existing regulations on the topic. The requirements of this guideline also concern medicinal products which are already available on the market. Read more here.

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14.02.13

New EU Template for QP Declaration (IMPs)

The European Commission has published a draft template for the QP's declaration concerning GMP compliance of IMPs manufactured in non-EU countries. Read more.

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