Clinical Trials Major development in EC guidance

Call for Comments on EMA Draft Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products with closing date February 28, 2017
Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
>> Template for your Comments


Four new public consultations concerning good manufacturing practices and clinical trials for human medicinal products were opened August 28, 2015 with closing date November 24, 2015

As a consequence of implementation of the Clinical Trial Regulation 536/2014:

Directive 2003/94/EC is repealed and replaced by
– a Delegated Act on principles and guidelines of GMP for IMPs
includes a link to GMP for Advanced Therapy IMPs
>> Synopsis Directive 2003/94/EC and Delegated Act
>> Template for your comments on delegated Act on principles and guidelines of GMP for IMPs

– a new Implementing Directive on principles and guidelines of GMP for medicinal products for human use,
meaning that Dir 2003/94/EC is split into two new documents, one for IMPs and one for commercial MPs.


Advanced Therapies major developments
Good Manufacturing Practice for Advanced Therapy Medicinal Products
Consultation Document closing date November 12, 2015
>> Template for your comments on GMP for ATMPs


Annex 13 will be deleted from EudraLex Vol 4 when the new guidelines
Detailed Commission guidelines on GMP for IMPs for human use become operational, carrying over relevant principles of Annex 13
>> Synopsis of Annex 13
>> Template for your comments on detailed Commission guidelines on GMP for IMPs


Directive 2005/28/EC is repealed
the Detailed arrangements for clinical trials inspection procedures including the qualification and training requirements for inspectors carries over to the extent possible the principles and guidance set out in Chap 5 & 6 of Dir 2005/28/EC. Additional provisions are introduced to include more detailed arrangements