Compliance
EU data protection bodies back clinical trial harmonization under the draft Biotech Act, but insist on strong safeguards for sensitive health data.
In 2026, the Danish inspectors plan to focus on whether drug manufacturing procedures still match the approved marketing dossier, and will require wholesalers to show that the computerized systems used in distribution are fit for purpose.
From enforcing new GMP norms to risk-based inspections and 850 CAPA notices, India’s drugs regulator is moving to tighten compliance across domestic pharma units. A striking step up in the regulator’s internal scientific cadre and more regulatory rationalization are also on the cards.
New compliance measures for big pharma under the amended EU sustainability reporting and due diligence directives could lead to new contractual requirements for smaller partners.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
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.