A step towards Global Regulatory Harmonisation?
Regulatory Authorities are facing an increasing workload as a result of the growing number of generic applications on one hand, and the demand for accessible, lower-cost quality medicines on the other.
In an attempt to address this issue, Regulatory Authorities have tried to set the grounds for collaboration, towards a faster mechanism for the approval of generic products. As a result, the International Generic Drug Regulators Pilot (IGDRP) was launched in 2012, with the participation of the Regulatory bodies of EU (EMA), USA, Canada, Australia, Singapore, Switzerland, Brazil, China, Chinese Taipei, Republic of Korea, Japan and Mexico. Since its first launch, the Regulatory bodies of New Zealand, Russia and South Africa have also joined the IGDRP.
Resolving issues in relation to public health or community interest
The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for preparing opinions on behalf of the European Medicines Agency (EMA) for any issues or questions regarding veterinary medicines. The CVMP referral procedure is used to resolve any issues that may be raised in relation to a veterinary product’s impact on public health or in cases where community interest is called into question.
A referral can be initiated for a number of reasons, as outlined below, under EU pharmaceutical legislation for veterinary medicines (Directive 2001/82/EC, as amended):
Most Common referrals:
Article 33: Mutual-recognition procedure (MRP) and decentralised procedure (DCP) referral
Article 34: Divergent decision referral
Article 35: Community interest referral