Regulatory Blog

Good Manufacturing Practice (GMP) serves as the backbone of pharmaceutical quality assurance. It ensures that medicinal products are...

The pharmaceutical industry continually evolves to adapt to new scientific discoveries and technological advancements. Good Manufacturing...

When navigating Switzerland's regulatory landscape for medicinal products, two key guidance documents from Swissmedic stand out for their...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S)  has released its " Guidance on Remote Assessments " effective from January...

This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment...

Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...

Blood establishments play a crucial role in ensuring a safe and adequate supply of blood for transfusion and other medical purposes. To...

Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...

Earlier today (09-January-2022), the Drug Regulatory Authority of Pakistan released an updated guidance on "Good Manufacturing Practices...

On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...

On August 28, the Saudi Food and Drug Authority updated its "Guide to Good Manufacturing Practice for Medicinal Products". The new...

As part of the manufacturing import authorisation (MIA) process, the Annex outlines the GMP requirements that must be followed when...

On 1-February 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP)...

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released guidance on the distant assessment of good manufacturing practices...

World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and...