Protecting public health whilst maintaining the free movement of herbal medicinal products
The 2004/24/EC Directive’s aim is to protect public health while at the same time maintain the free movement of herbal medicinal products within the Community by streamlining the registration process. While most individual herbal medicinal products have continued to be licensed nationally by Member States, the process for licensing has been increasingly harmonised across the European Union.
ISO Identification of Medicinal Products (IDMP) legislation
The ISO Identification of Medicinal Products (IDMP) standard, mandated by the European Medicines Agency (EMA) effective on 1 July 2016, poses a significant compliance challenge for the pharmaceutical industry. The main aim of IDMP is to define a universal ID for a medicinal product that can be cross-referenced in Individual Case Safety Reports (ICSRs) and support product reconciliation across the entire product supply-chain.
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.