On 24 March 2006, EMEA published a working plan of the working groups for
GCP and GMP inspection services. In the months to come, EMEA intends to
advance a whole number of activities concerning the GMP-compliant
manufacture of investigational medicinal products. Among them are the
following:
- Working out questions and answers in order to clarify/explain point
42 of Annex 13 (special regulation for packaging and labelling). This
includes the assimilation of the requirements laid down in Directive
2005/28/EC (Article 9.2).
- Determining the content of the "Batch Release Certificate"
- Adapting Annex 13 with regard to the new Annex 19 on retention and
reference samples
- Creating a guidance on transport and storage conditions for
investigational medicinal products (IMPs)
What is particularly interesting is the fact that the EMEA intends to
analyse the draft guidance on GMP requirements in clinical phase I
recently published by the FDA. In doing so, the authority wants to
evaluate in how far the EU should adapt its own GMP requirements on the
early stages of clinical trials. Read the details of this FDA initiative
in our GMP
news of 9 February 2006.
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