USA, FDA launched Guidance Snapshots

A brand pilot program has been launched in February 2020 by the US FDA on Guidance Snapshots. These new Guidance …

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UK will not be acting as a leading authority for medicines during Brexit transition

UK will not be acting as a leading authority for medicines during Brexit transition. Medicines and Healthcare products Regulatory Agency …

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USA, FDA’s launch of purple book, an online database for biologics

The US Food and Drug Administration launched the first version of the Purple Book, which is a searchable online database …

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India’s central government to regulate all medical devices as drugs

All medical devices in India will be regulated as drugs under Drugs and Cosmetic Act of 1940 with effect from …

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Implementation of eCTD for Clinical Trial Applications in Canada

Health Canada would be accepting certain clinical trial submissions in the format of electronic common technical document (eCTD) from 19 …

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New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia

New regulations on Duties and Obligations of Establishments for Medical Devices in Malaysia Coming into effect on the 1st of …

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Philippines’ executive order on medicine price cap

Philippines’ President Rodrigo Duterte officially signed the executive order which would see a cap set on selected medicines at a …

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Japan, Changes to medical device regulations

An official announcement was made in regards to the adoption of a new version of the Pharmaceuticals and Medical Devices …

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Indonesia, Directorate of Assessment providing assurance for medical devices and healthy products

Directorate of Assessment Indonesia is providing an assurance for medical devices and household health supplies distributed. Before products enter the …

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