Compliance

India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.

Buoyed by the milestone AbbVie deal, Glenmark expects to “pay down” its debt and is also changing certain legacy practices as it seeks to ascend the value chain to become more of a branded company.

A pair of Form 483 reports detail numerous observations of GMP violations at Hetero Labs’ facilities, exposing systemic quality and documentation failures, including the presence of lizards, birds, and cats.

Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.

Two of Latin America’s biggest regulators have signed a memorandum of understanding to deepen cooperation and improve access to medicines.

Berlin medtech associations add to European voice requesting that the EU eases MDR/IVDR and other compliance costs on SMEs.

Generic drug industry representatives applauded the FDA decision to bring back key staff in the Office of Generic Drugs that were laid off earlier this year.

The Drug Regulatory Authority of Pakistan has adopted a new benchmark for good manufacturing practices, ensuring that the quality and safety of medicines produced in Pakistan meet international standards.

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Clinical-stage reformulation specialist Lipella Pharmaceuticals has insisted that “our commitment to our shareholders, our mission, and our clinical goals has not changed” after its common stock was delisted from the Nasdaq Capital Market.

Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.