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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


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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 ....

United States , European Union , Preparedness Plan , Pharmaceutical Inspection Co Operation Scheme , Regulatory Authorities , Good Manufacturing Practice , South America , Pharmaceutical Quality Systems , Quality Control , Outsourced Activities , Product Recall , Medicinal Product Annexes , ஒன்றுபட்டது மாநிலங்களில் , ஐரோப்பிய தொழிற்சங்கம் , ப்ரிப்யாரெட்நெஸ் திட்டம் , மருந்து ஆய்வு இணை செயல்பாடு திட்டம் , ஒழுங்குமுறை அதிகாரிகள் , நல்ல உற்பத்தி ப்ர்யாக்டீஸ் , தெற்கு அமெரிக்கா , மருந்து தரம் அமைப்புகள் , தரம் கட்டுப்பாடு , ஒஉட்சௌூறசெட் நடவடிக்கைகள் , ப்ராடக்ட் ரீகால் ,

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


No need for jab to be approved by WHO, says FDA
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published :
13 May 2021 at 08:06
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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. ....

United Kingdom , Astrazeneca Covid , Paisarn Dunkum , Sinovac Covid , Prequalification Programme , Drug Administration , World Health Organisation , Use Listing Procedure , Pharmaceutical Inspection Co Operation Scheme , ஒன்றுபட்டது கிஂக்டம் , உலகம் ஆரோக்கியம் ஆர்கநைஸேஶந் , பயன்பாடு பட்டியல் ப்ரொஸீஜர் , மருந்து ஆய்வு இணை செயல்பாடு திட்டம் ,

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 Narendr ....

Enrique Gonzalez , Narendra Modi , Ambitech Biopharmaceuticals Inc , Ip Biotech Inc , Drug Administration , Indian Council Of Medical Research , Manila Times Covaxin , Emergency Use Approval , Philippine Food , Good Manufacturing Practices , Pharmaceutical Inspection Co Operation Scheme , Bharat Biotech , Indian Council , Prime Minister Narendra Modi , Ambitech Biopharmaceuticals , President Duterte , Republic Act , நரேந்திர மோடி , இப் பயோடெக் இன்க் , இந்தியன் சபை ஆஃப் மருத்துவ ஆராய்ச்சி , அவசரம் பயன்பாடு ஒப்புதல் , பிலிப்பைன் உணவு , நல்ல உற்பத்தி ப்ர்யாக்டிஸஸ் , மருந்து ஆய்வு இணை செயல்பாடு திட்டம் , பாரத் பயோடெக் , இந்தியன் சபை ,