Regulatory Blog

Artificial Intelligence (AI) is no longer a future concept in pharmaceutical research—it is already influencing how drugs and biological products are discovered, developed, manufactured, and monitored throughout their lifecycle. However, when AI outputs are used to support regulatory decisions , questions of trust, transparency, and accountability become critical. Recognising this, global regulators have begun defining expectations for the responsible use of AI in drug devel

As innovation in healthcare rapidly expands across digital health, medical devices, and advanced clinical trial designs, regulatory expectations must evolve in parallel. Recognising this shift, the US Food and Drug Administration (FDA) released and updated several key guidance documents in January 2026 , offering clarity on how emerging technologies and novel scientific approaches should be developed, evaluated, and regulated. These guidances collectively address clinical dec

The U.S. Food and Drug Administration announced the availability of a draft guidance for industry titled " M4Q(R2) The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality. " Prepared under the International Council for Harmonisation (ICH), this draft establishes a globally harmonized framework for organizing and presenting quality data in registration applications for human medicines. It updates the CTD's quality section to enhance registr

In the ever-evolving world of pharmaceutical and medical product regulation, correctly classifying your product is crucial. Some products fall into a “grey area” where they could be regulated as a medicinal product, a medical device, or another type of product such as a cosmetic, food supplement, or biocide. To help manufacturers and other stakeholders make this determination, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) publishes detailed guidance on h

In the United Kingdom, the regulatory landscape operates under a well-defined set of guidance documents established and maintained by the UK Government and the Medicines and Healthcare products Regulatory Agency (MHRA). These documents help sponsors, regulatory affairs teams, and clinical operations professionals comply with UK law while ensuring patient safety and data integrity. In 2026, several key guidances outline the authorisation process, trial notifications, reporting

In 2026, several key guidances published on GOV.UK clarify the rules manufacturers, sponsors, and regulators must follow for clinical investigations, market placement, conformity assessment, and exemptions. This blog covers four major guidances released and maintained by the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Government. Collectively, they form an essential framework for anyone involved in medical device development, clinical evaluation, reg

The 10th edition of the Indian Pharmacopoeia 2026  was launched by the Union Health Minister in the first week of January 2026 with 121 new monographs, Indian Pharmacopoeia 2026 ha now 3,340 monographs. The Indian Pharmacopoeia is now recognized in 19 countries. Guidance Document on Compounding of Offences under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025   This guidance has been issued by the Central Drugs Standard Control Organization (CDSCO) to support r

The Operational Information Sharing Guidance   published by the Medicines and Healthcare products Regulatory Agency (MHRA) provides structured instructions for Marketing Authorisation (MA) applicants on how to consent to the sharing of operational information during the MA application process. This guidance supports improved planning across the UK health system to enable faster and more efficient patient access to newly authorised medicines. This applies to applications submi