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.
Turkey is the 6th largest pharmaceutical market in Europe and the 16th largest pharmaceutical market in the world, and is classed as one of the fastest growing emerging markets. Pharmaceutical companies in Turkey have started to specialize in biotechnology based treatments due to increasing and changing health demands in Turkey as well as other pharmemerging markets. In Turkey, an applicant who intends to obtain approval of a “biosimilar product” must submit an “abridged” application to the General Directorate of Pharmaceuticals and Pharmacy. In the same way as an application in the EU, the applicant should demonstrate the similarity of the biosimilar product to the reference product (already authorized original biological product) in terms of its quality, characteristics, biological activity, safety and efficacy. In addition, the clinical trial data can be presented from clinical trials undertaken outside of Turkey, with the relevant approval from the competent authority.