Geography

China’s State Council has released a wide-ranging set of policy incentives intended to eliminate regulatory barriers and improve market access for innovative drugs.

2024 saw important regulatory changes in India including in areas such as GMP, clinical trials and efforts to rein in unethical marketing practices. Further action is expected to play out in the new year as well.

Major foreign pharma industry groups in Japan are threatening to pull out of a planned public-private council initiative over a proposed sales tax on certain drugs to fund drug discovery.

The policies for China’s biopharma industry in 2024 centered around innovative small molecules, biologics and cell and gene therapies. Regulation changes for the industry in 2025 could be a continuation of that.

The European Medicines Agency wants to work with other regulators as well as industry, scientists and patients to “find solutions for the most pertinent problems in psychedelic research” and improve treatment options for psychiatric disorders more broadly, says the agency.

A working group of EU regulators has developed a comprehensive repository of fee requirements relating to the Clinical Trials Regulation to help sponsors navigate the diverse demands of member states in the European Economic Area.

Boehringer Ingelheim “made it more difficult” for doctors to prescribe generic versions of its Spiriva (tiotropium) inhalers, Romania’s Competition Council has found, as it levied a fine of more than $25m on the German originator.

The European Medicines Agency has published new policies on handling conflicts of interests for its scientific committee members, experts and management board members.

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.

Final guidance on remote and hybrid good manufacturing practice inspections from the global inspectorate body, the PIC/S, aims to enhance inter-agency communication, improve reliance on inspections and ensure efficient use of global resources.

Clinical trial sponsors should strive to strike a balance between privacy and transparency at the very beginning of a trial to be successful, advises Certara’s Honz Slipka.

Two transparency experts share best practices for writing clinical study reports to protect patient privacy.

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. 

El Salvador has approved a law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

Mexico aims to speed up the registration of generics and biosimilars.

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.

The World Health Organization has also prequalified the Bavarian Nordic vaccine to enable broader and timely access.

Companies marketing pharmaceutical products in Saudi Arabia are being urged to prepare for upcoming mandatory pharmacoeconomic assessments to demonstrate the added value of their drugs over existing treatments.

The outgoing FDA commissioner, who placed much of the blame for tough calls on small companies that conduct inadequate clinical programs, defended his policy to not overrule center directors, but added that he did not entirely exclude himself from some of the agency's most controversial drug reviews.

At the J.P. Morgan Healthcare Conference, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA Commissioner Scott Gottlieb warned of threats to public safety.

Novel agents from the biologics center had a median review time of 10.6 months, beating the drugs center's median of 11.8 months thanks to fewer multicycle and more priority reviews.

Review times for all 61 novel agents the US FDA approved in 2024.