GMP News - Pharmaceutical Development / Clinical Trials / GCP

05.06.14

New Procedure for co-ordinating GCP-Inspections

The EMA GCP Inspectors Working Group has published the Procedure for coordinating GCP inspections requested by the CHMP describing the  the different steps of the Good Clinical Practice (GCP) inspection process. Read more.

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05.06.14

New Clinical Trials Regulation published

The new Clinical Trials Regulation has been published in the Official Journal of the EU. Read more.

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05.06.14

How to release IMPs in the EU

The release of Investigational Medicinal Products (IMPs) or Clinical Trial Material (CTM) for clinical trials in the EU can be very complex. Read here what needs to be considered.

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14.05.14

Different Storage Conditions and Stability Characteristics for Generics and Innovator Product: Is that allowed?

The EMA has recently extended its Q&As document with 2 questions/answers about differences between the properties of a generic product and those of an innovator product which could lead to medication errors. Read more here.

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07.05.14

Q&A: New Rules for Clinical Trials conducted in the EU

Following the positive vote in Parliament for the new Clinical Trial Regulation, the EU Commission has published a set of Q&As on clinical trials. Read more.

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07.05.14

Clinical Trials Regulation adopted in Parliament

The new EU Clinical Trials Regulation has been recently adopted by the EU Parliament. Read more about the objective and new developments.

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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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