PXL/HO/Cir-041/2019-20 Date: 26.07.2019
Subject: Block your diary: Pharmexcil organising International Regulators Meeting during 19-20 Sep.2019 at Taj Krishna, Hyderabad
We are glad to inform the member companies that Pharmexcil with the support of Ministry of Commerce & Industry, Government of India, is organising International Regulators Meet on 19th & 20th Sep.2019 at Taj Krishna hotel, Hyderabad.
Members are kindly aware, knowledge on regulatory/registration procedures is vital for the export of pharmaceutical products and these regulations vary from country to country and dynamic in nature. It is crucial for the exporter to have know-how on various amendments being made by the Food and Drug Authorities across the globe with respect to the product registration requirements (DMF and ANDA filings), documentation, filings, plants audits and inspections etc.
Pharmexcil with the support of Department of Commerce has initiated a programme “IKEP-International Knowledge Exchange Programme” and created a platform for inviting Food & Drug Regulatory officials globally. We have successfully organized interactive meets with some of the drug regulators including UKMHRA, NAFDAC, PMDA, DAV, ANVISA, Food & PB Kenya, EDA (Egypt), FDA Ghana etc.
In continuation of our efforts to promote Brand India Pharma globally and regulatory outreach, Pharmexcil as one of the approved activity of Ministry of Commerce & Industry under MAI Scheme, organising the “International Regulators Meet” inviting Food & Drug Regulatory Officials during 19-20th September 2019, from all regions, with a focus on the major export destinations.
The objectives of the Regulatory Meet are
· Outreaching the Food & Drug Regulatory officials and to create confidence in India Pharma
· Brand Building India Pharma and create awareness on Regulatory practices across the regions
· Possible cooperation on Harmonization of regulatory standards within India and globally.
· Showcase India Pharma as a dependable source for supply of quality generics at affordable prices to the global community
· Creating awareness to the member companies on regulatory procedures of various countries
· Providing an opportunity to member companies to interact with the Food and Drug Authority officials
Pharmexcil has invited Food & Drug Authorities from important destinations of India’s exports which include USA, United Kingdom, South Africa, Russia, Brazil, Nigeria, Germany, Canada, Belgium, France, Australia, Kenya, United Arab Emirates, Vietnam, Philippines, Nepal, China Sri Lanka, Netherland, Myanmar, Bangladesh, Thailand, Iran, Uganda, Japan, Spain, Italy, Turkey, Tanzania, Mexico, Korea, Saudi Arabia, Argentina, Indonesia, Ghana, Ethiopia, Egypt, Mozambique, Singapore, Hungary, Congo, Zambia, Ukraine, Algeria, Iraq, Slovenia, Sudan, Afghanistan, Yemen, Israel, Malaysia, Zimbabwe, Peru, Argentina, Uzbekistan, Kazakhstan, New Zealand etc.
Council has invited officials from WHO India Office and CDSCO officials to take part in the International Regulators Meet.The meet is proposed to be organised with CDSCO as co-organsier*
This is a unique opportunity for member companies to interact and network with Food and Drug Authority officials from across the globe and also to understand the recent changes in the regulatory procedures. We are confident this will facilitate every member company to have first-hand information and enhance product registrations and exports of pharmaceutical products and services from India.
The two-day programme is planned to have regulatory session’s and one to one interaction with the FDA officials from across the regions. We, therefore, request member companies to kindly block your dates of 19th Sep and 20th September 2019 and actively participate in the International Regulators Meet. Information regarding registration for the programme and forms will be shared with the next circular.