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Regulatory Pathways Are Opening Up Globally for Biosimilars

Implementation of biosimilar legislation in India and Brazil, an increase in drug review staff in Japan, and the publication of a draft monograph for monoclonal antibodies to be included in the Chinese pharmacopeia are among the regulatory efforts taking place across the globe that expand the opportunities for biosimilars....

China Projected to Become Major Global Vaccine Supplier with WHO Imprimatur and Overhauled Regulatory Infrastructure

The World Health Organization (WHO) certification of China’s FDA (SFDA) as a “competent authority,” and the quality regulatory upgrades the WHO imprimatur reflects, have opened the door for China to become a major player in the global marketplace for vaccines, WHO Director-General Margaret Chan said at the 65th World Health Assembly held in late May in Geneva, Switzerland....

Virtual Innovator Vertex Pioneers New QbD Course with CMO Partners

A clear communication pathway with contract partners for escalating issues during and after development has been key to Vertex’ success in building state-of-the-art, quality-by-design (QbD) applications as a virtual company....

EMA Process Validation Draft Targets Filing Requirements and Assessor Needs

The European Medicines Agency (EMA) has released a draft process validation (PV) guideline that mirrors FDA’s PV guide in principle, but is aimed more at the content and assessment of marketing authorization applications rather than the execution of validation in a manufacturing facility....

USP Announces Memorandum of Understanding with South Korean FDA

USP and the South Korea Food and Drug Administration (KFDA) have signed a memorandum of understanding (MoU) that seeks to identify areas of collaboration between the organizations, raise awareness of the importance of the quality and safety of medicines, and identify areas of mutual interest. KFDA Commissioner Hee-Sung Lee and USP CEO Roger Williams signed […]

USP Announces New Pharmaceutical QC Training Center in Africa; IOM Report Details Regulatory Shortfalls in Region

USP is planning to extend its effort to help Africa better assure the quality and integrity of its pharmaceutical supply with a new USP training/laboratory center slated to be located in Ghana....

PIC/S Provides Guidance to Inspectors on Assessing Quality Risk Management

The inter-agency Pharmaceutical Inspection Cooperation Scheme (PIC/S) has released an “Aide-Memoire” intended to assist GMP inspectors in assessing industry’s implementation of quality risk management (QRM) and to help promote a harmonized approach among PIC/S member states....

Several Drug Substance Guideline Initiatives Moving Forward in Europe and ICH

Europe and ICH have several guideline initiatives underway that will help clarify and harmonize the regulatory expectations for drug substances and the control of their impurities....

EDQM Intensifies Focus on Biotech; USP Also Advancing Biotech Coverage

In mid-February, the European Directorate for the Quality of Medicines & HealthCare (EDQM) announced an ambitious set of efforts aimed at ensuring that the European Pharmacopeia (Ph. Eur.) texts and monographs appropriately cover biologic products, including cellular and gene transfer products and host cell-derived proteins....

US/Canada Regulatory Cooperation Council Addresses DMF, GDP and OTC Harmonization

At the end of January, over 240 industry representatives and US and Canadian government food and drug officials met in Washington, DC to review progress and provide direction to working groups dealing with the 29 initiatives included in the US/Canada Regulatory Cooperation Council’s Joint Action Plan.  Initiatives on harmonizing regulatory standards for drug master files […]
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