Regulatory Blog

The 10th edition of the Indian Pharmacopoeia 2026  was launched by the Union Health Minister in the first week of January 2026 with 121 new monographs, Indian Pharmacopoeia 2026 ha now 3,340 monographs. The Indian Pharmacopoeia is now recognized in 19 countries. Guidance Document on Compounding of Offences under the Drugs and Cosmetics (Compounding of Offences) Rules, 2025   This guidance has been issued by the Central Drugs Standard Control Organization (CDSCO) to support r

The Operational Information Sharing Guidance   published by the Medicines and Healthcare products Regulatory Agency (MHRA) provides structured instructions for Marketing Authorisation (MA) applicants on how to consent to the sharing of operational information during the MA application process. This guidance supports improved planning across the UK health system to enable faster and more efficient patient access to newly authorised medicines. This applies to applications submi

For generic drug developers, receiving tentative approval (TA)  for an Abbreviated New Drug Application (ANDA) is a major milestone—but it is not the end of the regulatory journey. Moving from tentative approval to final FDA approval  requires careful planning, timely submissions, and technically compliant study data. To support applicants, the FDA has issued two complementary guidance documents: ANDA Submissions — Amendments and Requests for Final Approval to Tentatively App