GMP News - Pharmaceutical Development / Clinical Trials / GCP

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

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.

more

GMP Newsletter

Sign up for the free of charge newsletters.

Sign up now!

GMP Conferences by Topics