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Devicemakers need to ensure their subsidiaries working in foreign markets are aware of a U.S. anti-bribery law or — as Johnson & Johnson (J&J) may find all too soon — they could face multimillion-dollar fines and possible jail time for their officers.
Fees collected by the Danish Medicines Agency (DMA) for applications to conduct clinical trials on new medicines rose Jan. 1 to 7,010 Danish kroner (Dkr).
Australia’s Therapeutic Goods Administration and New Zealand’s Medicines and Medical Devices Safety Authority have issued a draft rule on advertising of therapeutic products under the proposed trans-Tasman regulatory agency.
The Taiwanese Department of Health’s Bureau of Pharmaceutical Affairs (BPA) has developed new rules on pharmaceutical preparations, source materials, processes, quality control, safety and efficacy involving genetically altered drugs.
South Africa’s Medicines Control Council, a division of the Department of Health, has issued final guidance on how and when to submit information related to changes to drugs listed in the country’s medicines register.
Health Canada has released draft guidance for manufacturers and healthcare professionals detailing procedures under the special access program (SAP) for drugs.
The Indian national government last month approved the creation of an autonomous unit to regulate the import, licensing, quality and safety of pharmaceutical and medical device products.
The European Medicines Agency (EMEA) has issued guidance addressing questions that users of the agency’s “New Framework for Scientific Advice & Protocol Assistance” may have.