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Gene Therapy HTA: How Do The European, Australian And Canadian Systems Shape Up?

A report comparing the health technology assessment methods used in nine European countries, Australia and Canada found that England has the most favorable reimbursement landscape for gene therapies – but outlined several areas for improvement across the board.

Europe International

Panel Tells Canadian Govt A Subscription-Style Pull Incentive Is Needed To Tackle AMR

An expert panel formed by the Council of Canadian Academies says drug developers that provide “novel, valuable antibiotic solutions” should be rewarded with a “fair and reasonable guaranteed revenue” for their drugs.

Canada Regulation

Mexico To Expand Recognition Of International GMP Certificates For Biologic Medicines

Moves to widen GMP certificate recognition are in line with World Health Organization recommendations on Good Reliance Practices and with the Mexican government’s strategy for regulatory certainty for the pharmaceutical sector, says the country’s drugs regulator.

Mexico Policy

Global Pharma Guidance Tracker – August 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

South Africa ‘Forced To Overpay’ For COVID-19 Vaccines Under ‘One-Sided’ Contracts

Companies and organizations that signed the contracts deny any heavy-handedness, with Johnson & Johnson saying it worked closely with South Africa on vaccine supply, and the vaccine alliance Gavi noting that the COVAX Facility provided the country with more than nine million doses free of charge.

Middle East and Africa South Africa

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.

International Europe

How To Use The UK’s New International Recognition Pathway For Drug Approvals

Eligibility criteria, how to apply, 60-day and 110-day timetables, major objections and clock stops. These are among the topics that the Medicines and Healthcare products Regulatory Agency covers in newly published guidance for drug companies planning to use the soon to be launched IRP.

United Kingdom International

South African Agency To Help National Regulators Build Up Their Capacities

RCORE designation means SAHPRA can support training and exchange programs as part of pan-African regulatory strengthening moves.

Middle East and Africa South Africa

Canada Builds On RWE Guidance

Industry representatives are invited to join a new task force to help advise on how industry-gathered real-world evidence should be used in regulatory and health technology assessment decision making.

BioPharmaceutical North America

Canada Updates 18-Year-Old Guide On What Constitutes Advertising

Keeping press releases about a product on the manufacturer's website landing page for more than a year may be considered to be promotional, according to Health Canada's update guidance that includes myriad revisions, including a new section on using social media.

Canada Advertising, Marketing & Sales

South African Court Orders Release Of COVID-19 Vaccine Contracts

The High Court’s decision could have consequences for the negotiation of vaccine contracts in other countries and might also lead to a strengthening of the provisions on transparency and accountability in talks on a future pandemic treaty, says the Health Justice Initiative.

South Africa Coronavirus COVID-19

Brazilian Regulator Creates New Committee To Take Part In Drug Approvals

Anvisa’s new committee is expected to improve the drug registration process.

South America Brazil

Canada To Start Temporarily Reimbursing Drugs That Need More Evidence

Manufacturers participating in CADTH's new time-limited funding mechanism must submit updated clinical trial data within the agreed-upon time or their funding will be terminated and any existing patients will become their responsibility.

Canada Cost Effectiveness

Boost For South African Agency’s Regulatory Oversight Of Vaccine Manufacturing

The donation of equipment to SAHPRA may be a small step in the greater scheme of things, but every little helps when it comes to building up Africa’s self-sufficiency in vaccine production.

BioPharmaceutical Vaccines

Saudi FDA Mandates Child-Resistant Packaging For Medicines With Significant Toxicity Risk

Drug companies operating in Saudi Arabia have 18 months to comply with new requirements for child-resistant packaging of medicines that can have dangerous consequences for children if accidentally ingested.

Saudi Arabia Regulation

Firms Await Brazilian Regulator’s Decision On Allowing ‘Skinny Labels’ For Generics

The Brazilian medicines regulator, ANVISA, is considering whether to allow generic drug labeling to omit indications of the originator product that are still under patent. "Skinny labels" also figure in an ongoing court case involving Boehringer Ingelheim's Ofev (nintedanib).

South America Brazil
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