• Indian and European leaders discussed how to strengthen regulatory cooperation in the fields of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practise) during a joint workshop in India.
  • Topics on mutual reliance, globalization and GCP and GMP compliance were addressed during the sessions.
  • The workshop gathered key authorities, regulators and senior pharma executives from India and Europe for the first time.

Medicines for Europe and Pharmexcil today organised a Workshop on Global Pharmaceutical Operations in New Delhi, gathering key authorities, regulators and senior pharma executives from India and Europe for the first time. During the workshop, the conference participants debated on mutual reliance with regard to the effects of globalisation and the interplay of trust, regulation and business; how to create a universally acceptable quality culture in relation to GCP (Good Clinical Practice) and GMP (Good Manufacturing Practice) compliance and how to foster regulatory cooperation between the EU and India.

India and Europe are two major centres for pharmaceutical development, clinical development and manufacturing. There are opportunities to strengthen the global competitiveness of these two centres through cooperation. Close cooperation and trust between regulators and industry in both regions can support a positive environment for business cooperation based on mutual reliance. One of the tools through which this trust can be built is through regulatory collaboration and by partnering with stakeholders in the globalised market to ensure full understanding of the requirements of good practice.

Adrian van den Hoven, Medicines for Europe Director General commented: “The globalisation of the pharmaceutical industry operations has fuelled a debate internationally regarding opportunities, challenges related to regulation across the manufacturing supply chain. Medicines for Europe supports regulatory cooperation with our partners to ensure effective and efficient regulation for better access to high quality medicines for patients in India and in Europe”.