The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are likely sign a pact for mutual recognition of drug facility inspections in January 2017. In the wake of this landmark development which would transform the speed of global audits, Indian pharma industry is hoping that this pact would be extended to the Asian region which includes India.
 
Kaushik Desai, pharma consultant said, “The discussions between EMA and USFDA have been going on for some time and it is heart warming to note that this is now taking shape. Currently these inspections are only between the EU countries and the US. But it is very important for the regulatory authorities to extend the same to Asia because it would particularly make considerable business sense since India accounts for the highest number of USFDA plants outside of the US and also has a substantial number of EMA approved facilities in the country.”
 
“If this is extended to India, then it would bolster the ease of doing business with global pharma majors. India is already a hub for contract manufacturing. The country’s high quality- skilled talent pool and advanced production plants are already engaged in manufacture of many drugs for international pharma companies. Having dual inspections of the two global regulatory teams of EMA and USFDA would shorten time of approval and reduce the repetitive audit processes. This is the best which could happen and can be viewed a global audit harmonisation platform,” noted Desai.
 
According to the European Compliance Academy (ECA) section titled GMP Compliance news, "The state-of-play and the organisation of the evaluation of the US and the EU GMP inspectorates were discussed. In light of the progress achieved, the conclusion of a mutual recognition agreement of Good Manufacturing Practices (GMPs) inspections by January 2017 is under consideration."
 
Further it stated that European Commission has indicated, “Some issues are still not resolved - like, for example, the exchange of confidential information and the inclusion of veterinary products in the scope of the text.”

In the Report of the 15th Round of Negotiations for the Transatlantic Trade and Investment Partnership held between October 3 and 7, 2016 in New York indicates, “Good Regulatory Practices (GRP) and Regulatory Cooperation was a topic deliberated in a constructive manner. Considerable progress was made in clarifying the concepts for GRP which included in particular provisions related to early regulatory planning, impact assessment and ex-post evaluations, transparency. For regulatory cooperation in particular, proposals from stakeholders and provisions governing regulatory cooperation between the parties was highlighted. The institutional framework for regulatory cooperation was also discussed at the ‘Chief Negotiators' level.”