Study quantifies drug revenue invested in R&D

International – Study quantifies drug revenue invested in R&D

A coalition of the drug industry’s fiercest foes is accusing the world’s top drug makers of hiding behind research and development “as an excuse...
WHO Drafts Policy on Designating Regulators as Listed Authorities

International – WHO Revises Guidance on QMS Requirements for National Inspectorates

The World Health Organization (WHO) has revised its guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates to align with international...
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...
Bientôt en ligne : nouveau site Pharmeuropa

International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments

La Direction européenne de la qualité du médicament & soins de santé (EDQM) et l’ANVISA, l’agence brésilienne de surveillance sanitaire, ont annoncé aujourd’hui avoir...
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)...
Valsartan prices double after recall

International – Valsartan prices double after recall

Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a...
NICE rejects Keytruda, asks for more info

International – NICE and Canadian counterpart to offer joint advice service

The service will offer guidance that will help pharma develop value-based evidence by providing feedback on the company’s clinical and economical evidence generation plans. Feedback...
FDA Seeks Comment on ICH Guideline on Optimizing Safety Data Collection

International – ICH Drafts Revised Guideline on General Considerations for Clinical Studies

With a focus on modernization, the International Council for Harmonisation (ICH) on Thursday released for public consultation a draft version of its guideline E8(R1)...
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)...
WHO Drafts Guideline on Data Integrity for Pharmaceuticals

International – WHO Drafts Guideline on Data Integrity for Pharmaceuticals

The World Health Organization (WHO) recently drafted a new guideline on data integrity that explains the important elements to ensure the reliability of data...

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