Geography

US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.

Multiple, wide-ranging revisions to Japan's PMD Act, including provisions on pediatric R&D, use of real-world data and cell therapies, look set to receive formal political approval within the next few months. There is also more clarity on a controversial scheme to support venture companies.

In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.

The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.

The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.

Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.

France’s health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures.

Manufacturers should make use of joint scientific consultations under the EU Health Technology Assessment Regulation, but they must pay close attention to the selection criteria as consultation slots are limited, experts say.

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.

The World Health Organization (WHO) has launched an initiative to highlight the pressing global need to reduce the impact of the pharmaceutical industry on the environment while maintaining high standards of safety and efficacy for products.

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

Modernized good clinical practice principles finalized by the International Council for Harmonisation focus on fostering a quality culture, proactively designing quality into trials, identifying factors critical to trial quality, engaging interested parties, and using a proportionate risk-based approach.

Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.

Health technology assessment bodies in England, the US, Canada, Australia, the Netherlands and Colombia have joined forces to produce guidance for drug developers on using surrogate endpoints for cost-effectiveness analyses.

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

Mexico is to establish a new regulatory framework that is in line with international standards to encourage domestic production of biosimilar medicines. 

Efforts have stepped up to enhance Africa’s capacity to meet international good manufacturing practice standards, empower regulators across the continent, and drive sustainable growth in the pharmaceutical sector.

Japan ships the first batch of 50,000 mpox vaccine doses to DRC after training local healthcare providers dealing with the persistent outbreak.

Egypt is the first African country to win a WHO maturity level 3 benchmarking rating for medicines and vaccines that are locally produced and imported.

A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.

US President Trump’s plan for a “25% or higher” tariff on pharmaceuticals promises to have a far-reaching impact, from higher prices and drug shortages to increased onshoring of manufacturing in the US. Is MAGA worth the chaos it might create for MAHA? The Indian industry shares its views.

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

The pharmaceutical industry has been quiet on Trump's early federal government overhauls that could harm the drug business, still betting he will help produce better results than Biden.

The "interwoven" nature of the offices within the agency likely means Medicare and Medicaid benefits may be disrupted by staff cuts despite assurances from the administration, Brooks-LaSure warned.