Swiss and Korean Regulators Agree to Mutually Recognize GMP Inspections

International – Swiss and Korean Regulators Agree to Mutually Recognize GMP Inspections

Swissmedic and South Korea’s Ministry of Food and Drug Safety (MFDS) agreed last month to mutually rely on each other’s good manufacturing practice (GMP)...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – Improving Biosecurity with first International Standard for Biorisk Management

SARS, pandemic viruses and threats of the malicious use of pathogens have all woken the world up to the risks of biological materials and...
EU-China Working Group to Address API Manufacturing Concerns

International – EU-China Working Group to Address API Manufacturing Concerns

As active pharmaceutical ingredient (API) quality concerns linger, China’s National Medical Products Administration (NMPA) has agreed to work with the European Commission’s DG Sante,...
Drugmakers working on powerful, targeted cancer treatments

International – Drugmakers working on powerful, targeted cancer treatments

Dozens of drugmakers are conducting human trials for a record 89 therapies that pair antibodies with toxic agents to fight cancer, evidence of renewed...
ASEAN Adds Philippine FDA to GMP Mutual Recognition Program

International – ASEAN Adds Philippine FDA to GMP Mutual Recognition Program

The Philippine Food and Drug Administration (FDA) has joined a regional mutual recognition program. As part of the Association of Southeast Asian Nations (ASEAN)...
WHO drafts guidance for pharma supply chain tracking

International – WHO prequalifies first biosimilar medicine to increase worldwide access to life-saving breast...

Today the World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving treatment...
4 Trends and Expectations for Drug Delivery in 2020

International – 4 Trends and Expectations for Drug Delivery in 2020

Recent years have seen considerable developments in the delivery of injectable medications. Modern patients, demanding drug therapies that are both effective and convenient to...
The Transformation of Digital Health: What it Means for Regulatory Professionals

The Transformation of Digital Health: What it Means for Regulatory Professionals

Articles throughout November focused on what the changing digital health landscape, including big data, means for regulatory professionals. Leaders in the digital health space...
PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With Risk-Based Change Management

International – PIC/S Looks to Help Inspectors Gauge the Effectiveness of a PQS With...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) last week published a draft recommendation offering guidance for good manufacturing practice (GMP) inspectors seeking to evaluate the...
WHO drafts guidance for pharma supply chain tracking

International – Information Note Nitrosamine impurities

Background Medicine Regulatory Authorities first became aware of the presence of the nitrosamine impurity, Nnitrosodimethylamine (NDMA), in products containing valsartan in July 2018. Valsartan is...

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