Regulatory Blog

Good Clinical Practice (GCP) serves as the foundational ethical and scientific standard that governs how clinical trials involving human participants are designed, conducted, recorded, and reported. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) enforces these standards to protect participant safety and the integrity of clinical data. The official guidance on Good clinical practice for clinical trials  explains how sponsors, investigator

As regulatory systems evolve globally, Switzerland continues to harmonize and strengthen its medicinal product oversight through guidance that combines scientific rigor with procedural clarity. Two recent Swissmedic documents— the guidance on the Procedure with Prior Notification (PPN)   and the technical interpretation on environmental conditions for microbiological examination of non-sterile products — together illustrate how Swiss authorities aim to improve both regulato

As pharmaceutical modalities diversify—from traditional injectables to complex biologics, cell therapies, inhalation products, and medical gases—the integrity of container closure systems, delivery devices, manufacturing components, and raw materials has never been more critical. The FDA’s recent guidances reflect this evolving reality and aim to tighten quality expectations across the entire product lifecycle. Three key guidances are: Current Good Manufacturing Practice for

The U.S. FDA has released a draft guidance titled Cross-Center Master Files: Where to Submit , issued in November 2025 addressing a longstanding challenge in regulatory operations: determining which FDA center  should host a master file (MF) when the file must support multiple regulatory submissions across different FDA centers. This guidance aims to reduce industry confusion, avoid duplicate submissions, and streamline review processes when MFs are used across drugs, biolog

Paediatric drug development remains one of the most complex regulatory areas in the pharmaceutical landscape. Scientific uncertainty, evolving clinical insights, and gaps in early evidence often make it difficult for developers to design complete paediatric programmes at the initial stages of development. Recognising these challenges, the European Medicines Agency (EMA) has introduced a specialised mechanism known as the stepwise Paediatric Investigation Plan (sPIP) , formall

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) updated the section 3.1: 'Implementation of new guidelines' through its official guidance titled Medicines: Apply for a Variation to your Marketing Authorisation   — a key reference for MA holders operating in the UK regulatory ecosystem. A variation is any change to the terms of an existing marketing authorisation, from simple administrative updates to changes that may affect quality, safety or efficacy. T

The South African Health Products Regulatory Authority (SAHPRA) has released the Guidelines to Good Manufacturing Practice for Medicines , effective 17 November 2025. This updated guideline aligns South Africa with the latest PIC/S GMP standards and strengthens regulatory expectations for manufacturers, importers, exporters, and distributors operating within the South African market. GMP is a system ensuring that medicinal products are consistently produced and controlled

The European Medicines Agency (EMA) recently published new guidance titled “ Guidance for applicants: the ETF Scientific Advice that facilitates Clinical Trial Authorisations (SA-CTA ) ”, outlining how sponsors and applicants can benefit from harmonised scientific advice to accelerate clinical trial authorisation across the EU. 1. What the SA-CTA Scientific Advice Is The guidance explains that the SA-CTA scientific advice is a specialised type of EMA advice developed under th

The European Medicines Agency (EMA) has released a major draft guideline " Non-Inferiority and Equivalence Comparisons in Clinical Trials "  that updates how non-inferiority and equivalence comparisons should be designed, justified, and analysed in confirmatory clinical trials. This draft replaces two earlier documents: Guideline on the choice of the non-inferiority margin  (2005), and Points to consider on switching between superiority and non-inferiority  (2000). The new gu

The U.S. Food and Drug Administration (FDA) has released a final Guidance for Industry  yesterday (17 November, 2025) titled “ Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use ” that is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or otic use in seeking approval of a drug that is qualitatively (Q1) different

Conducting clinical investigations for medical devices in the UK requires strict adherence to MHRA’s updated regulatory framework, designed to support patient safety, device innovation, and compliance with evolving UK (and EU for Northern Ireland) requirements. The guidance  “ Notify MHRA about a clinical investigation for a medical device ” provides a clear roadmap for manufacturers, sponsors, and investigators who plan to conduct clinical investigations of medical devices i

The UK regulatory environment now offers two important pathways for bringing innovative medicinal therapies to patients: The Early Access to Medicines Scheme (EAMS) , which permits earlier availability of new medicines under conditions of unmet medical need; and The MHRA’s guidance “ Clinical trials for medicines: apply for authorisation in the UK ” , which provides the regulatory framework for initiating clinical trials of investigational medicinal products. These 2 guidance

The South African Health Products Regulatory Authority (SAHPRA) has issued an updated "Guideline for Destruction of Medicines and Scheduled Substances" outlining the safe and compliant destruction of medicines and scheduled substances across the country. This update aligns regulatory expectations with the Medicines and Related Substances Act (Act 101 of 1965)  and the National Environmental Management: Waste Act (2008) , reinforcing SAHPRA’s commitment to protecting public

The U.S. Food and Drug Administration (FDA) has released its updated guidance “ How to Prepare a Pre-Request for Designation (Pre-RFD) ” , issued on November 6, 2025 . This guidance provides companies with a clear roadmap for obtaining early, non-binding feedback on the regulatory classification of their products — especially combination products , which often sit at the intersection of drugs, devices and biologics. The updated guidance strengthens transparency, clarifies ex

With the regulatory landscape evolving in the UK post-Brexit, manufacturers, importers, distributors and authorised representatives must be fully aligned with the registration requirements laid out by the MHRA. The guidance titled “ Register medical devices to place on the market ”  sets out the detailed steps, legal framework, responsibilities and timelines you must meet for compliant market entry. Under the guidance, every medical device  (including in-vitro diagnostics (IV

With the 2025 amendments to the Medicines for Human Use (Clinical Trials) Regulations taking effect on 28 April 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided comprehensive guidance “ Clinical trials for medicines: modifying a clinical trial approval”  for sponsors and investigators which outlines how to manage changes to an approved clinical trial of a medicinal product. Types of Modification Modifications to a clinical trial approval f