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August 18, 2017
CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.
August 10, 2017
The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.
June 12, 2017
The three regulatory agencies have agreed to data requirements for development of new antibiotics.
May 24, 2017
The agency met with the representatives of the East African Community to discuss the creation of a networking agency.
March 10, 2017
The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.
March 02, 2017
Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.
November 24, 2016
Domestic sales will be the key driver of revenue growth.
September 07, 2016
FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.
June 17, 2016
June 02, 2016
Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.