Responses to public consultations of several DRAFT GMP & GDP guidelines published

So called “public consultations” represent important means of the European Commission in Europe for involving interested parties in consensus building. This is also extensively used in the field of pharmaceuticals guidelines. Just recently, the responses to public consultations of three important DRAFT GMP & GDP guidelines have been published i.e.

  • Draft guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
  • Draft guidelines on the principles of good distribution practices for active substances for medicinal products for human use
  • Revision of EU Commission guidelines on Good Manufacturing Practice Medicinal Products, Part I, Chapters 3, 5, 6 and 8

Direct link to the concerned documents:

Non-recombinant, biological medicinal products: update on current EMA guidelines

”Biological medicinal products” are defined as a group of medicinal substances derived from biological sources such as heparins, gonadotrophins and urokinase. Due to the biological origin of the starting materials and intermediates used to manufacture these products and the related inherent risk, specific knowledge of the manufacturing process and its control is needed in order to ensure the quality and safety.

The EMA Guideline “Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products” (EMA/CHMP/BWP/429241/2013) will come into force December 1st, 2013. Just recently, the EMA drafted in addition the related Guideline “Guideline on the adventitious agent safety of urine-derived medicinal products” (EMA/CHMP/BWP/126802/2012) for public consultation (deadline for comments: May 31st, 2014).

See respective references:

  • Guideline on the use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products (EMA/CHMP/BWP/429241/2013)
  • Guideline on the adventitious agent safety of urine-derived medicinal products (EMA/CHMP/BWP/126802/2012)

UK-MHRA Website of Falsified Medicines Directive 2011/62

The UK competent health authority has published a well structured website concerning the Falsified Medicines Directive 2011/62. Due to the importance of this directive and frequent information requests we receive, this link is provided hereunder:

Major GxP Events III & IV/2013