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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.

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.

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.

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.

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.

English, Canadian and US HTA Bodies Team Up On Unpublished Clinical Data Transparency Drive
NICE, CADTH and ICER say they have taken a step toward greater transparency of unpublished data and a tangible outcome resulting from cooperation among global health technology assessment bodies.

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.

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.

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.

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.

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.

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.
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