Geography

China implements a new pilot scheme allowing non-end-to-end manufacturing of certain biologics before possible nationwide implementation for all such products, with resource optimization and aligned quality management systems among the main goals.

Japan has implemented a streamlined regulatory system designed to enable speedier approvals of selected drugs for designated categories of infectious diseases, which does not require Japanese clinical data.

A session at the recent KoNECT conference in Seoul looked at Korea’s strengths in clinical trials but also at what's needed to further improve its global competitiveness as a location for studies.

China has proposed new guidelines designed to head off potential bribery by pharma companies related to the conduct of clinical studies and possible manipulation of outcomes.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Hympavzi, Pfizer's treatment for adults and adolescents with severe hemophilia A or B without inhibitors.

The new court ruling could enhance the appeal of the Unified Patent Court for enforcing European patents.

The European Medicines Agency is encouraging companies to submit the type I variations they want to make to their marketing authorizations by the end of this month.

The European Medicines Agency wants to discourage drug companies from submitting marketing applications with very interim data cuts and then expecting they can supplement their application with more data later on by requesting for extended clock-stops.

The pharma industry wants regulators around the world to engage with companies and “articulate the value added” when introducing new regulations and guidance around the use of AI in drug development, AstraZeneca’s director for data and AI policy says.

Global regulators should work together on producing standard terminology around the use of AI in drug development to align as much as possible on their approaches, according to the Food and Drug Administration’s Tala Fakhouri.

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.

CRO executive Horst Ruppach discusses the critical factors that drug manufacturers must consider to ensure compliance with the revised ICH Q5A(R2) guideline on biologics viral safety. Thorough documentation and proactive engagement with regulatory bodies are key to navigating the complexities of viral safety evaluation in biotechnology products, he says.

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.

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 Democratic Republic of Congo, the country worst hit by the mpox crisis, has now received the first batch of vaccines for the disease. Meanwhile, the World Health Organization is expected to complete its review for emergency use listing of mpox vaccines soon.

Throckmorton is known for enhancing the FDA’s drug shortage work by building bridges between the compliance and quality teams, as well as opioid oversight.

Removing the patent-protected indication from the label of Norwich Pharmaceuticals's proposed generic for Xifaxan did not convince the US Supreme Court to hear its petition to review a case from Bausch Health that blocked approval until 2029.

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.

The atypical antipsychotic’s Risk Evaluation and Mitigation Strategy should be retired because the requirements for prescriber education and documentation on absolute neutrophil count monitoring are hindering access, panelists said.