Asia-Pacific Roundup: India waives local trial requirements for certain drugs
India’s Central Drugs Standard Control Organization (CDSCO) earlier this month announced that it will waive local clinical trial requirements for certain drugs approved in other countries.Specifically, CDSCO will waive the requirements for orphan drugs, cellular and gene therapies, new drugs used in a pandemic or “special defense” context, and new drugs with a significant therapeutic advantage over standard of care, if the drugs are approved by regulators in Australia, Canada, the EU, Japan, UK, or US.
The announcement, dated 7 August 2024, was issued in line with Rule 101 of the New Drugs and Clinical Trial Rules, 2019.
CDSCO
CDSCO issues draft pharmaceutical GDP guideline
Earlier this month, CDSCO issued draft guideline on pharmaceutical good distribution practices (GDP) for public comment.
The 25-page guideline is meant to guide drugmakers on the proper storage and distribution of pharmaceuticals, and “sets out steps to assist in fulfilling the responsibilities involved in the different stages within the supply chain and to avoid the introduction of spurious, adulterated, misbranded and not of standard quality products into the market.”
The guideline applies to all entities involved in the storage and distribution of drugs, including drugmakers, their agents, and dispensers. The guidance includes chapters addressing organization management, personnel, quality systems, premises, temperature and environmental control, transportation, documentation, complaints, recalls and returns, as well as handling of spurious product.
Interested parties have 30 days to submit comments on the draft guideline.
CDSCO
Other news:
The Turkish Medicines and Medical Devices Agency issued a communication on Monday alerting in vitro diagnostic (IVD) makers that the EU’s Commission Implementing Regulation (EU) 2022/1107 establishing common specifications for certain Class D IVDs entered into force last month. Announcement
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has announced two upcoming meetings. The agency announced that it will host the 12th annual Japan-Taiwan Medical Cooperation Conference in Nihonbashi, Tokyo on 7 October 2024. On 19 November 2024, the agency will hold its 8th PMDA Regulatory Science workshop, which will include lectures on recent academic papers and their impact on regulatory and business operations. Announcement 1, 2
South Korea’s Ministry of Food and Drug Safety (MFDS) announced that it has approved Eli Lilly Jaypirca (pertobrutinib) to treat mantle cell lymphoma. Announcement
China’s National Medical Products Administration (NMPA) announced that Covidien Medical International Trading has recalled its Video Laryngoscope and McGrath MAC Video Laryngoscope due to the risk of overheating battery components. Announcement
NMPA also announced that it authorized 272 medical devices in July 2024. Among the devices are 192 domestic Class III devices, 44 imported Class III devices, and 35 imported Class II devices. Announcement
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