EuropaBio submission to the European Commission Public Consultation on the comitology part of the revision of the Variations Regulations

04.01.2008

EuropaBio submission to the European Commission Public Consultation on the comitology part of the revision of the Variations Regulations

EuropaBio welcomes the opportunity to comment on DG Enterprise and Industry’s review of the current regulatory framework on changes to medicinal products (“Variations Regulations”) in the EU. 

Significant advances in biosciences and in manufacturing technologies have led to a steady increase of bio-pharmaceuticals and advanced bio-therapies that are depending on a regulatory framework that supports innovation and continual improvements to manufacturing processes without causing unnecessary delay in supplying these innovative products to the market.

The vast majority of changes to the manufacture and control of a biological medicinal product areexcluded from usage of the Type IA/IB notification submission route which requires significant administrative and regulatory resources, both for competent authorities and for the industry. EuropaBio considers that many of the changes outlined in Annex I of the current Regulations could be processed for biological products as a Type IA or IB notification, with no negative implications to quality, efficacy or patient safety.

We believe that there is opportunity to maintain or even increase the level of public health protection in simplifying the system without compromising human and animal health by allowing more human and fiscal resources be focused by the industry on greater innovation and efficiency in development of high quality, safe and effective medicinal products.