Regulation

After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.

A new report identifies opportunities to implement the 3Rs principle in India, calling for a waiver of redundant animal testing for generics and NCEs/NBEs and alignment with global regulatory frameworks. Will India shift gears to adopt harmonized NAM-first policies?

Agency exercises enforcement discretion on requirement for products to be labeled as containing artificial colors or dyes when those aren’t native to foods or ingredients, including added colors made from natural sources.

“Dietary Supplement Regulatory Uniformity Act” would prohibit states from adding requirements and rules for supplement manufacturing and sales on top of FDA regulations.

The clinical and statistical review teams favored a complete response letter for the vasculitis treatment, while the review division and office directors supported approval.

The US Supreme Court’s decision to review Hikma and Amarin’s litigation over induced infringement of carved-out patented indications offers a chance to resolve key questions around skinny-label generics, according to Chad Landmon, chair of law firm Polsinelli’s Hatch-Waxman & biologics practice.

India’s budget backs plans to scale production of biologics and biosimilars, shore up its clinical trials network and strengthen the regulatory framework. Customs duty exemptions given to several big pharma therapies, including those of Novartis and Takeda.

PharmAbcine founder shares views on current lack of post-delisting protections for technology companies in South Korea, proposing special regulations to safeguard expertise and assets for a certain period.

“FDA’s proposed GRAS rule would move GRAS closer to the NDI model in at least one key respect, which is mandatory notification,” says attorney Ashish Talati. Proposed rule isn’t expected to require removal of ingredients available through self-GRAS processes.

Huge opportunities for OTC therapies loom in India, as consumerization brings structural reset in healthcare. Success stories on Rx-to-OTC transition augur well for pharma, but a predictable regulatory roadmap will be pivotal for sustainable growth.

Huge opportunities for OTC therapies loom in India, as consumerization brings structural reset in healthcare, as per a new report by EY-Parthenon. Success stories on Rx-to-OTC transition augur well for pharma, but a predictable regulatory roadmap will be pivotal for sustainable growth.

Regulatory streamlining represents a paradigm shift for the biosimilars industry, but does it go far enough? Gillian Woollett, Samsung Bioepis’ head of regulatory strategy and policy, says streamlining must be accompanied by a sustainable economic environment for biosimilars to ensure global access.