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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a multi-year strategy aimed at ensuring continued patient-centered regulation in the era of emerging artificial intelligence (AI) and personalized medicine. The plan outlines commitments and steps the agency should take through 2030 to keep pace with rapid technological and scientific developments and bring safe and effective treatments to patients more quickly.

Stakeholders are urging the US Food and Drug Administration (FDA) to be flexible in how it regulates psychedelic drugs that may help treat conditions such as major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). The agency should be careful not to create unnecessary barriers to patient access, promote proper training and credentialing, and allow flexibility in updating labeling as additional knowledge becomes available, according to individuals and groups that commented via a public docket.

Broader adoption of cloud-based platforms by regulatory bodies could lead to significantly faster approval times, according to a study authored by Nina Cauchon of Amgen and colleagues published in the Journal of Pharmaceutical Sciences.

The number of clinical trials authorized in the EU and European Economic Area (EEA) has decreased by 13.5% from pre-pandemic levels as Asia has captured a growing share of clinical research.

The US Food and Drug Administration (FDA) last week finalized its guidance on postapproval manufacturing changes for biosimilars to better align with international guidelines and to better address manufacturing changes for interchangeable products, which were not addressed by earlier guidance.

Over the last 15 years, there has been an uptick in the number of patents associated with small-molecule drugs approved by the US Food and Drug Administration (FDA), with a majority of the increase linked to the use of non-primary patents, according to the results of a recent special communication published in JAMA.

The US Food and Drug Administration (FDA) recently released a transparency roadmap outlining its achievements in FY 2026 and its priorities for FY 2027. Two key priorities for the future include a proposal to require public disclosure of new drug applications (NDAs) and biologics license applications (BLAs) upon filing, as well as proactively publishing all inspection reports.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) is planning to update a 2018 guideline on good pharmacogenomic practices. While the guideline is less than a decade old, the pace of change in pharmacogenomics has prompted regulators to revisit their recommendations.

The Medicines and Healthcare products Regulatory Agency (MHRA) says the UK government has adopted a list of recommendations on the use of artificial intelligence (AI) in medical devices developed by an independent group of doctors in the National Health Service (NHS). The agency also said it is initiating the third phase of its AI Airlock, a regulatory sandbox for evaluating new AI products.

The World Health Organization (WHO) has issued an updated draft guideline to assist manufacturers establish an effective quality risk management (QRM) system and to help regulators in planning their inspections. The guidance incorporates concepts from the International Council for Harmonization’s (ICH) Q9 (R1) guideline on quality risk management (QRM).