Regulatory Blog

Before approving a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), the U.S. Food and Drug Administration (FDA) must ensure that the manufacturing facilities are capable of consistently producing medicines that meet Current Good Manufacturing Practice (CGMP) requirements. Preapproval Inspections (PAIs) are conducted to evaluate manufacturing readiness, verify the accuracy of Chemistry, Manufacturing and Controls (CMC) information, and confirm that facili

Innovation is transforming medicinal product development through the introduction of novel methodologies such as biomarkers, digital health technologies, artificial intelligence (AI), modelling and simulation, real-world data, patient registries, and advanced non-clinical testing methods. These approaches have the potential to improve evidence generation, streamline drug development, and support more informed regulatory decision-making. However, before they can be widely adop

Timely access to innovative medicines and biosimilars is an important objective for regulatory authorities worldwide. Collaborative assessment models enable regulators to share scientific expertise, reduce duplication of effort, and accelerate the availability of high-quality, safe, and effective medicines for patients. International work-sharing initiatives also promote regulatory convergence while maintaining robust scientific evaluation standards. The Medicines and Healthc

Access to accurate and up-to-date medicinal product information is essential for the safe prescribing, dispensing, and use of medicines. Healthcare professionals rely on authorised product information to make informed clinical decisions, while patients depend on clear instructions to use medicines safely and effectively. Providing easy access to approved regulatory information also promotes transparency throughout a medicine's lifecycle. The Medicines and Healthcare products

Pharmacovigilance plays a critical role in protecting public health by enabling the timely identification, assessment, and management of medicine safety concerns. Accurate reporting of adverse drug reactions (ADRs) and Adverse Events Following Immunisation (AEFIs) allows regulatory authorities to continuously monitor the benefit-risk profile of authorised medicines and implement appropriate regulatory actions when necessary. To strengthen electronic pharmacovigilance reportin