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  • Regulatory NewsRegulatory News

    Generic drugmakers get cannabidiol bioequivalence guidance from FDA

    Manufacturers who seek to produce generic versions of cannabidiol oral solution received guidance from the US Food and Drug Administration (FDA) on establishing bioequivalence with the reference listed drug.   The guidance follows the June 2018 approval of Epidiolex (cannabidiol) oral solution to treat seizures associated with two rare and serious types of childhood epilepsy. Epidiolex was also approved to treat a third seizure condition, tuberous sclerosis complex, in...
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    Medical cannabis regulation is a global patchwork

    (Editor's note: this article was updated to clarify which products made from cannabis or hemp plants fall under Health Canada's Natural Health Products category.) The framework for regulating cannabis as a pharmaceutical product varies widely across the world, though increased clinical research into cannabis products means more approvals are likely under any scenario.   “It’s currently a complex patchwork of approaches,” Michael Craig, a principal consultant at Pa...
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    Cannabis clinical research clarified in draft guidance

    A new draft guidance from the US Food and Drug Administration (FDA) provides detailed information on the conduct of clinical research using cannabis and cannabis-derived compounds, including how to calculate levels of delta-9 tetrahydrocannabinol (THC), cannabis’ main psychoactive ingredient.   The draft guidance recommendations, which pertain only to human drug development, “are intended to provide clarity” in the wake of the 2018 Farm Bill, which removed low-delta-...
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    RoundupsRoundups

    Asia Regulatory Roundup: TGA Proposes Ban on Certain Breast Implants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Proposes Ban on Certain Breast Implants After Safety Review   Australia’s Therapeutic Goods Administration (TGA) is planning to cancel the licenses of nine Natrelle textured breast implants made by Allergan. TGA proposed the action, plus the suspension of 16 other devices, after reviewing evidence of links between breast implants and a form of lymphoma.   Ove...
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    FDA Warns Four Companies Selling Cannabidiol Over Unproven Claims

    The US Food and Drug Administration (FDA) on Wednesday warned four companies selling cannabidiol (CBD) containing products for making claims that their products can treat or cure cancer and other diseases, including Alzheimer's, arthritis, heart disease and stroke. "Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act , but also can put patients at risk as these products have not bee...
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    FDA Considers WHO Scheduling Change for 17 Drug Substances

    The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs. Background Section 201 of the Controlled Substances Act (CSA) provides that when WHO notifies the US under Art...
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    FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

    The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances. The comments received will be considered in preparing the US position on these proposals for a meeting of the UN Commission on Narcotic Drugs (CND) in Vienna, Austria,...
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    Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Starts Review of Drug Recall Guidelines The Drugs Consultative Committee (DCC) of India has committed to reviewing the guidelines on drug recalls to ensure substandard products are effectively removed from the market. Officials want to make manufacturers monitor the quality of drugs in the supply chain and hold them responsible for voluntarily recalling products that ...
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    FOIA'd Documents Show FDA's Rationale Against Marijuana Rescheduling

    In a report and other documents obtained by Vice News via the Freedom of Information Act (FOIA) , the US Food and Drug Administration (FDA) lays out its case against rescheduling marijuana. FDA's recommendation on the matter was cited by the Drug Enforcement Administration (DEA) when it denied two petitions to reschedule marijuana last August . Despite efforts by medical marijuana advocates and a growing number of states (25, plus the District of Columbia) where med...
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    UK’s MHRA: Products Containing Cannabis Extract are Medicines

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recently come to the decision that products containing cannabidiol (CBD) are a medicine, following a regulatory review of such products. “We have come to the opinion that products containing cannabidiol (CBD) are a medicine. Products for therapeutic use must have a medicines’ licence before they can be legally sold, supplied or advertised in the UK. Products will have to meet safety, quality a...