News about Regulation

FDA Issues Complete Response Letter for Disc Medicine's Bitopertin in Rare Blood Disorder

US regulator seeks Phase III APOLLO trial results before approving bitopertin for erythropoietic protoporphyria, pushing potential decision until mid-2027.

Regulation | 19/02/2026 | By News Bureau |  309

IPC Signs Three MoUs to Strengthen Medicine Safety and Quality Standards

The Indian Pharmacopoeia Commission (IPC)has signed three MoUs to strengthen medicine safety and quality, including partnerships with the Goa State Pharmacy Council (GSPC)and the Quality Council of India (QCI) to boost pharmacovigilance, training and healthcare quality initiatives.

Regulation | 10/02/2026 | By News Bureau |  304

FDA Issues 11 Observations to Aurobindo Pharma Manufacturing Facility

Aurobindo Pharma has reported that its formulation manufacturing facility in Telangana received 11 procedural observations from the United States Food and Drug Administration (FDA) after a routine inspection.

Regulation | 09/02/2026 | By Darshana |  1035

GSK Wins European Nod for Nucala to Treat Eosinophilic COPD

GSK plc has received European Commission approval for Nucala (mepolizumab) as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by elevated blood eosinophils, despite treatment with inhaled triple therapy.

Regulation | 07/02/2026 | By Darshana |  216

FDA Warns It Will Take Action on Misleading Copycat Drug Marketing

The United States Food and Drug Administration (FDA) has warned it will take swift action against companies that mass-market unapproved “copycat” drugs by promoting them as if they were similar to FDA-approved products, the agency’s commissioner said.

Regulation | 06/02/2026 | By Darshana |  178

Government Imposes Minimum Import Price on Key Antibiotic APIs to Support Domestic Manufacturing

The Union Ministry of Commerce and Industry has imposed a Minimum Import Price (MIP) on three key active pharmaceutical ingredients—penicillin and its salts, amoxycillin and its salts, and 6-aminopenicillanic acid (6-APA)—for a period of one year.

Regulation | 03/02/2026 | By Darshana |  1328

USPTO Issues New Patent to Acurx for DNA Polymerase IIIC Inhibitor Technology

The newly granted patent covers DNA polymerase IIIC inhibitors, including compositions of matter, methods of use and pharmaceutical formulations, further strengthening Acurx’s Intellectual Property (IP) portfolio and expanding its growing patent estate in the US and international markets.

Regulation | 03/02/2026 | By News Bureau |  215

Union Health Ministry Revises NDCT Rules

The Union Health Ministry has notified amendments to the NDCT Rules, 2019 to ease compliance and speed up drug development, introducing a prior-intimation mechanism in place of licensing, waiving permissions for select low-risk BA/BE studies, and cutting test licence processing timelines to 45 days.

Regulation | 28/01/2026 | By News Bureau |  214

FDA Publishes Guidance on Modern Statistical Methods for Clinical Research

The FDA guidance provides a framework for applying Bayesian analyses in clinical research, enabling data-driven assessments of safety and efficacy using both current and prior evidence.

Regulation | 14/01/2026 | By News Bureau |  208

WuXi Biologics' Wuxi Facilities Receive MHRA GMP Approval for Ophthalmic Biologic Manufacturing

The UK regulator has certified WuXi Biologics’ DP5 and DPPC sites in Wuxi for commercial production, reinforcing the company’s global GMP-compliant manufacturing capabilities.

Regulation | 13/01/2026 | By News Bureau |  321