News about Regulation

IPC Signs MoU with UPPPC to Strengthen Quality, Innovation, and Regulatory Excellence in Healthcare

The Indian Pharmacopoeia Commission (IPC) has signed a Memorandum of Understanding (MoU) with Uttar Pradesh Promote Pharma Council (UPPPC) to enhance pharmaceutical quality, healthcare innovation, regulatory compliance, and MSME support through digital reporting tools.

Regulation | 16/07/2026 | By News Bureau

UK and EU Drug Regulators Sign Working Arrangement

The UK government and the EU Drugs Agency have signed a working arrangement to strengthen regulatory cooperation, protect public health, and reduce drug-related harms.

Regulation | 16/07/2026 | By News Bureau

Leiutis Pharma Announces CDSCO Approval for World's First Synthetic CBD Anxiety Therapy

Leiutis Pharmaceuticals has received CDSCO approval for the world's first synthetic CBD oral solution to treat mild to moderate anxiety disorders alongside cognitive behavioral therapy.

Regulation | 15/07/2026 | By News Bureau |  1788

US FDA Accepts BioMarin's sNDA for VOXZOGO in Achondroplasia

The US Food and Drug Administration (FDA) has accepted BioMarin's sNDA for VOXZOGO in achondroplasia, supported by long-term safety and efficacy data, including adult height, body proportionality, and arm span outcomes.

Regulation | 14/07/2026 | By News Bureau

US FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer's Disease

The US Food and Drug Administration (FDA) has approved Leqembi Iqlik (lecanemab-irmb) as a once-weekly subcutaneous starting dose for early Alzheimer's Disease (AD), with a U.S. launch planned for August 2026.

Regulation | 14/07/2026 | By News Bureau

NMPA Reviews QMS for Vaccine and Drug GMP Compliance

China's NMPA has completed a QMS management review to strengthen vaccine and drug Good Manufacturing Practice (GMP) compliance, supporting WHO WLA standards and PIC/S regulatory requirements.

Regulation | 13/07/2026 | By News Bureau

US FDA Approves PADCEV Plus Keytruda for Muscle-Invasive Bladder Cancer

The US Food and Drug Administration (FDA) has approved PADCEV plus Keytruda as the first and only platinum-free neoadjuvant and adjuvant treatment for adults with Muscle-Invasive Bladder Cancer (MIBC), regardless of cisplatin eligibility.

Regulation | 13/07/2026 | By News Bureau

US FDA Proposes New Rule to Modernise Drug Manufacturing Registration

The US Food and Drug Administration (FDA) has proposed a new rule to modernise drug manufacturing registration, streamline advanced distributed manufacturing, and improve visibility into foreign drug supply chains.

Regulation | 13/07/2026 | By News Bureau

India and Australia Sign CSIR-TKDL Pact to Protect Traditional Knowledge

CSIR and IP Australia have signed a Traditional Knowledge Digital Library (TKDL) access agreement at the India-Australia Summit to strengthen traditional knowledge protection.

Regulation | 13/07/2026 | By News Bureau

Government Revises Drugs Rules to Regulate High Alcohol-Content Medicines

India has strengthened regulation of high alcohol-containing drug formulations by bringing products with over 12 percent v/v ethyl alcohol under Schedule H1 and ending their Schedule K exemption.

Regulation | 10/07/2026 | By News Bureau |  158