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Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

The Philippine Food and Drug Administration (FDA) is holding a consultation into plans to update and standardize the contents of the License to Operate (LTO) for pharmaceutical establishments.

India's Central Drugs Standard Control Organization (CDSCO) has introduced draft legislation describing the requirements for informing authorities of manufacturing changes.

The Indian Council of Medical Research (ICMR) has outlined plans to adopt a single ethics committee review mechanism for clinical trials.

BALTIMORE – While it's important for regulatory professionals to translate regulatory intelligence to company leadership, it's also important to focus on providing essential information for their operations rather than inundating them, according to a panel of experts.

Australia's Therapeutic Goods Administration (TGA) has proposed changes to the compliance program for its charge exemption scheme to address an increase in issues with the initiative.

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is running a consultation into the rules and guidelines for seeking approval of medicines via the consent by verification pathway.

The Pharmaceuticals and Medical Devices Agency (PMDA) is coordinating with other Japanese bodies to offer a one-stop service platform for biotechs that want to run clinical trials in the country.

The US tends to receive regulatory submissions earlier and more often than other major international regulators, but there was a similar rate of submissions across regulators for oncology drugs and those deemed by authorities of having moderate-to-high therapeutic value, according to recent research published in Health Affairs.

The Central Drugs Standard Control Organization (CDSCO) has started a consultation on guidance about importing in vitro diagnostics (IVDs) into India.

China has updated the implementation of its Drug Administration Law, setting out plans to revise its drug research and registration system and make other changes to support innovation.

India's Central Drugs Standard Control Organization (CDSCO) is halving turnaround times for some clinical trial submissions as part of a raft of reforms to the regulation of drug development. The New Drugs and Clinical Trials (Amendment) Rules, 2026 update the original 2019 legislation.

The Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to extend the abbreviated procedure for new medicine applications and certain change notifications.

China has updated its drug regulations, leading the National Medical Products Administration (NMPA) to set out its areas of focus under the new framework.

India's Central Drugs Standard Control Organization (CDSCO) has proposed removing cough syrups from the list of medicines that can be sold without a prescription.

Currently, the standards TGO 91 and TGO 92 establish the rules for the information that companies must include on the labels of prescription and over-the-counter (OTC) medicines, respectively. The TGA stated that the existing standards have helped make important information easier to find on medicine labels, but that there are opportunities to reduce regulatory burdens and provide medicine sponsors with more clarity.

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has finalized its revised guidance on running studies to show products are bioequivalent.