Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Other Countries

Set Alert for Other Countries

Don’t Reveal Patients’ Safety Data Just Because They Have, Trial Sponsors Told

A transparency consultant says companies should not be pressured into revealing sensitive safety data under clinical trial transparency initiatives even if this information is made available by trial participants themselves on social media sites.

Canada Compliance

Canada Consults On Policy Changes For Registering Clinical Trials & Disclosing Results

Health Canada is taking steps to improve transparency on authorized clinical trials and is creating a new trials search portal.

Clinical Trials Guidance Documents

Brazil To Use Regulatory Reliance For GMP Inspections

Brazil’s medicines regulator Anvisa is considering new rules that would define regulatory reliance procedures for inspections and good manufacturing practice certification.

Brazil South America

Global Pharma Guidance Tracker – February 2023

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

Removing Confidential Data In Clinical Trial Reports Is ‘Like Stepping On Lego’

An expert in transparency explained what drug sponsors can do to support their compliance staff in identifying commercially confidential information in accordance with the clinical trial transparency initiatives of Health Canada and the European Medicines Agency.

Compliance Clinical Trials

Global Pharma Guidance Tracker – January 2023

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

Canadian Court Upholds New Drug Price Comparison Basket – With Caveats

A Canadian court has dismissed an appeal brought by industry challenging new pricing rules that introduce a revised basket of reference countries as part of cost-containment measures.

North America Canada

Canada’s Controversial Pricing Guidelines Suspended

The implementation of new pricing guidelines that are unpopular with the pharmaceutical has been put on hold, to the relief of the pharmaceutical industry.

North America Canada

Ethiopian Regulators To Take Part In Work Of European Pharmacopoeia

Ethiopia is the latest African country that the European Pharmacopoeia Commission has accepted as an observer.

Ethiopia Europe

Global Pharma Guidance Tracker – December 2022

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

Canada Wants More Agility And Alignment In Drug Regulations

The Canadian regulator has proposed several changes to current drug regulations to deliver on its modernization commitments and leverage long-standing policies and practices.

Canada Regulation

Global Pharma Guidance Tracker – November 2022

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
See All
UsernamePublicRestriction

Register