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Brazilian Regulator Extends COVID-19 Measures

Brazil’s medicines regulator is extending COVID-19 era resolutions designed to speed up its evaluation of clinical research in Brazil.

South America Brazil

Canada Publishes Real World Evidence Guidance For HTA And Regulatory Decision Making

The new guidance was drawn up through extensive engagement with national and international experts in RWD and RWE, as well as stakeholders in Canada.

North America Canada

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Clinical Trials Health Technology Assessment

Mexico, Colombia and Cuba Formalize Talks On New Latin American Regulator

Medicines regulators from Mexico, Colombia and Cuba have pledged to create a new agency for medicines and medical devices of Latin America and the Caribbean.

South America North America

Global Pharma Guidance Tracker – April 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

English, Canadian and US HTA Bodies Team Up On Unpublished Clinical Data Transparency Drive

NICE, CADTH and ICER say they have taken a step toward greater transparency of unpublished data and a tangible outcome resulting from cooperation among global health technology assessment bodies.

United Kingdom Canada

International Regulators’ Consortium Offers Joint Pipeline Discussions With Pharma

Regulators in Australia, Canada, Singapore, Switzerland and the UK are offering to host joint pipeline meetings under the ACCESS Consortium initiative to advise drug companies on their future product development plans.

Regulation United Kingdom

WHO Inaugurates South African mRNA Technology Hub

More than 200 people took part in a meeting to assess progress with an mRNA technology transfer program that is intended to give manufacturers in lower-income countries the ability to produce and sell their own vaccines for COVID-19 and other diseases.

International South Africa

Latin America Sets Sights On Creating New Regional Medicines Regulator

Regulators in Mexico, Colombia and Cuba have affirmed plans to create a new Latin American and Caribbean Medicines Agency.

North America Mexico

Brazil Publishes New Guidelines On Registering Medicines

Anvisa, Brazil’s medicines regulator, has published guidelines on registering synthetic and semi-synthetic medicines using new pathways.

South America Brazil

Global Pharma Guidance Tracker – March 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 Action On Rare Disease Is A ‘Step Forward,’ Says Industry

Canadian rare disease drugs strategy is expected to improve access to treatments and the collection and use of real-world evidence.

North America Canada
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