ICG A3P Regulatory
Relying on the expertise of members of the regulatory texts and to respond to a request of its members, A3P created a Common Interest Group (CIG) regulations.
This GIC A3P regulation has two main objectives:
• A goal Proactive →The review of the regulatory texts in draft.
• A goal Educational →Explain the approved Statutory Instrumentsto make them more understandable.
The analyzed texts will be new versions of chapters 3 5 & the European GMP, closely linked to increased levels of requirements to improve the prevention of cross-contamination.
Goal : Dissect these new versions, prepare questions on inaccurate or misunderstood items for submission to health authorities to initiate an exchange.The goal is to issue a guide which will then be broadcast to the entire profession.
|being analyzed texts||State|
|- New version of the chapters of the European 3 5 & GMP
|- Draft EMA "Guideline on the sterilization of the medicinal product,
active substance, excipient and primary container "
The April 13 2016, the EMA (European Medicines Agency) published the draft "Guideline on the sterilization of the medicinal product, active substance, excipient and primary container" for consultation until October 13 2016. (Download the draft )
Under the regulatory GIC, the A3P gives you the opportunity to participate in this consultation and to issue comments. If you or industrial supplier and concerned by this new guideline and have experience and / or expertise in the field of sterilization products so A3P offers to join a working group of about 10 people. This animated by Jonnathan Tafforin et Dominique Weil will aim to analyze and comment on the guideline and then submitted to the EMA consolidated comments before October 13 2016.
The first working session organized around the 15 June according to the availability of the participants will be followed by 2 or 3 other sessions by the end of September.
The permanent members of the ICG A3P Regulatory committee :
- Anne RIGOULOT - Sanofi Pasteur
- Vincent GRIFFOUL - Debiopharm
- Vincent VANDAMME - GSK Vaccines
- Jonnathan Tafforin - Recipharm