GMP News - Pharmaceutical Development / Clinical Trials / GCP

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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14.02.13

New Eudralex Vol.10 Guidance

The EU Commission has published a technical guidance providing a visual representation of the clinical trial results data that is required to be captured by EudraCT. Read more.

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14.02.13

EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline

Antimicrobial resistance is an important issue for the marketing authorisation of veterinary medicinal products. On January, the European Medicines Agency published a concept paper for a guideline on antimicrobial resistance risk assessment. It is open for public consultation now. Find out more.

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14.02.13

Responses to the public Consultation on the Paediatric Regulation

The results of a public consultation on the experience acquired with the Paediatric Regulation have been published. Read more.

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14.02.13

New Guidance for Recall of IMPs

The European Commission has published the revised EU-GMP Chapter 8 on Complaints, Quality Defects and Product Recalls. The chapter has been revised completely and also details additional requirements for recalling IMPs. Read more.

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15.11.12

EMA announces streamlining of activities of Committee for Advanced Therapies

To optimise the efficiency of EMA and the Committee for Advanced Therapies' in the field of ATMP, EMA has streamlined the activities of the CAT. More details here.

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15.11.12

Commitee for Advanced Therapy Medicinal Products (CAT) - Public Call for Expression of Interest

For membership in the Committee for Advanced Therapy Medicinal Products (CAT), the European Commisiion published a public call for interested representatives of patients' associates and clinicians. Read more here.

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09.10.12

US Government Report on Innovation in Pharmaceutical Development

The US President's Council of Advisors on Science and Technology (PCAST) has published a report to the President on propelling Innovation in Drug Discovery, Development and Evaluation. Read more.

 

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09.10.12

European Commission seeks Feedback on Paediatric Regulation

The European Commission has launched a public consultation on the experience gained with the paediatric regulation. Read more.

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09.10.12

Update of FDA Clinical Investigator Inspection List

FDA updates quarterly its Clinical Investigator Inspection List. The list contains names, addresses, and other information gathered from inspections of clinical investigators. Read more.

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