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FDA expands mutual reliance and harmonization with trusted foreign regulators for inspectional oversight - PIC/S GMP guide aims to strengthen the resiliency of globalized drug supply chains | Hogan Lovells

To embed, copy and paste the code into your website or blog: The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. Indeed, FDA was forced to accelerate its work to advance regulatory convergence with trusted foreign regulatory partners by sharing information to complete inspectional activities, to advance certain medical product applications through the review process, and to help mitigate potential drug shortages. FDA’s “Resiliency Roadmap for FDA Inspectional Oversight” issued this month, summarizes the agency’s use of alternative inspectional tools and priorities going forward, calling the work to further leverage information shared through mutual recognition agreements (MRAs) “increasingly vital.” For example, FDA assessed expanding the use of MRA beyond in-country inspections to include third-country inspec

No need for jab to be approved by WHO, says FDA

No need for jab to be approved by WHO, says FDA 8 published : 13 May 2021 at 08:06 8 The Food and Drug Administration (FDA) has confirmed that each country has the right to register Covid-19 vaccines that will be used by their people without relying on a vaccine list approved by World Health Organisation (WHO). Secretary-General of the FDA Paisarn Dunkum said Covid-19 vaccines approved according to the WHO Emergency Use Listing Procedure (EUL) are for use under the Covax initiative. The procedure can also be used as a reference when considering Covid-19 vaccine registration in countries with an incomplete vaccine regulatory system, he said.

India s Covaxin secures conditional EUA approval from PH FDA

India’s Covaxin secures conditional EUA approval from PH FDA The Manila Times © Provided by The Manila Times © Provided by The Manila Times Covaxin received Emergency Use Approval (EUA) from the Philippine Food and Drug Administration (FDA), conditional on its submission of Good Manufacturing Practices (GMP) certification from any country that is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). It is the fourth vaccine in the Philippines to be granted an EUA. The Philippines is the ninth country to grant the EUA to Covaxin, which has an 81 percent efficacy rate and is a traditional inactivated whole virion vaccine. It is the first indigenously-developed Covid-19 vaccine in India by Bharat Biotech in collaboration with the Indian Council of Medical Research. Covaxin has been safely used by millions of people in India’s Covid-19 vaccination program, with numerous government officials such as the Prime Minister Narendra Modi having rece

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