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Global

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How Inspectorates Will Judge Quality Systems' Ability To Manage Manufacturing Changes

PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.

Manufacturing Quality

PIC/S Advises On Safe On-Site Inspections During COVID-19 Pandemic

The international association of pharmaceutical inspectorates, PIC/S, has developed a structured process that national inspectors can use to assess their risk of exposure to COVID-19 when carrying out routine on-site inspections.

Coronavirus COVID-19 Guidance Documents

EMA Considers How To Verify Potency Of Next-Generation COVID-19 Vaccines

Companies approaching the European Medicines Agency with their development plans for new COVID-19 vaccines are being asked to consider immunobridging studies if placebo-controlled trials are not feasible.

Vaccines Coronavirus COVID-19

WHO Consults On Evaluating mRNA Vaccines For Infectious Diseases

The World Health Organization says there is a pressing need for guidance on the evaluation of mRNA vaccines because of the rapidity with which clinical trials have progressed for COVID-19 candidate vaccines, their emergency use approval or authorization, and their subsequent widespread use.

Vaccines Regulation

Global Regulators Focus On Promoting Reliance During Public Health Emergencies

Agencies participating in the International Pharmaceutical Regulators Programme discussed priorities, welcomed the UK as the newest IPRP member and endorsed a new regulatory tool to support the assessment of quality-related information in marketing applications.

International Regulation

Global Generics & Biosimilars Industry Sets Out Vision To 2030

Headwinds as well as opportunities for the off-patent industry are discussed in a comprehensive new whitepaper by the International Generic and Biosimilar Medicines Association

International Biosimilars

Global Pharma Guidance Tracker – June 2021

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation

Final PIC/S Data Integrity Guidance Encourages Foolproof Approaches To Drug Manufacturing Data

Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.

Manufacturing Quality

Petra Dörr: EDQM Appoints First New Director In 14 Years

The European Directorate for the Quality of Medicines & HealthCare, which is responsible for the European Pharmacopoeia, is to be led by former Swissmedic regulator and current World Health Organization executive Petra Dörr.

Quality Europe

Coronavirus Notebook: South Africa To Build mRNA Vaccine Tech Transfer Hub, EMA OKs More Comirnaty Production Capacity

MSF is pressuring Moderna and Pfizer/BioNTech to share their vaccine know-how with manufacturers in developing countries, and companies have just a few days to answer the European Commission's questions about COVID-19 therapies they have in development.

Europe International

PIC/S Wants To Know: What About ‘Authorized Persons’ For Batch Release Outside The EU?

International association of pharmaceutical inspectorates launches industry consultation on aligning with the one EU GMP provision it spurned years ago.

Manufacturing Quality

UK Regulator Eyes Expedited Process For Securing Full ICH Membership

The UK is on a mission to re-join the International Council for Harmonisation as a fully active member with voting rights.

United Kingdom International
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