March 2026
New EDQM guidance on requesting fast-track assessment of CEP applications, revisions & renewals:
This guideline provides information on how regulatory authorities & prospective CEP applicants can request fast-track assessment of CEP dossiers. The purpose is to address medicine shortages in Europe and also where fast-track assessment aligns with the objectives of EU 'Critical Medicines Act'*
The fast-track assessments conducted by the EDQM will still meet the same regulatory diligence and rigor as any standard CEP application.
[*In March 2025, European Commission proposed 'Critical Medicines Act' to improve the availability, supply & production of critical medicines within EU.]
Learn MoreJanuary 2026
EDQM: New General Chapter 'Quality of Data' available in Ph. Eur 📘
The new general chapter '5.38. QUALITY OF DATA' was made available in January with the release of version 12.3 of the European Pharmacopoeia (Ph. Eur. 12.3). 🗓️🆕
Published for information, this chapter addresses the quality of data, with a focus on data of digital origin 💻. It complements existing Ph. Eur. chapters that support digital & technological transformation in the pharmaceutical sector. 📲
This new chapter is a significant step in Ph. Eur.’s adaptation to the evolving digital landscape, ensuring that data used in decisions concerning pharmaceutical quality is robust, reliable & well-governed.
Key Highlights: It provides a framework for managing digital data quality across its entire life cycle. The complete chapter '5.38. QUALITY OF DATA' can be accessed in Ph. Eur. 12.3. 📖
Learn MoreDecember 2025
Congrats to Wockhardt Team!!! 👍 👏
Indian Pharma Milestone: Zaynich NDA Accepted by US FDA
- 1. Wockhardt Ltd. today announced that US FDA has formally accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich
- 2. The NDA was originally filed on September 30, 2025, and its acceptance marks a transformative moment—not only for Wockhardt, but for entire Indian pharmaceutical industry
- 3. This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharma company has been filed & accepted by US FDA
November 2025
The AI Rx: How Artificial Intelligence is Rewriting the Drug Discovery Timeline
The Future of Drug Discovery:
- Drug development faces ever-growing challenges: pipelines are expensive, timelines are long, and failure rates - high
- Novel therapeutic often takes over a decade & roughly $2.6 billion to reach patients, with fewer than 10% of candidates ultimately approved.
- Against this backdrop, artificial intelligence (AI) has moved from buzzword status to a key enabler in biotech and pharma R&D. AI applications deliver tangible value by significantly compressing development timelines.
Learn MoreOctober 2025:
From Application to Approval: The CEP Process Simplified
This document explains how to get a CEP/changes to a CEP approved. The process works the same way for all types of applications like: new applications, sister files (related applications), changes, renewals, notifications & transfers of the certificate holder. Main steps cover: Submission, Validation, Assessment, Decision
Learn MoreAugust 2025
FDA alerts drug manufacturers to the risk of benzene contamination:
Benzene is a known human carcinogen. Certain drug products, including hand sanitizers, benzoyl peroxide products [to treat acne & other skin conditions] & aerosol drug products have been recalled due to benzene contamination.
Learn MoreMay 2025
The much awaited draft is out, the M4Q[R2 guideline]
The Common Technical Document for the registration of pharmaceuticals for human use: Quality M4Q(R2)
This revision reflects significant updates and improvements to the original M4Q(R1) guideline
Learn MoreCDSCO inviting comments on 'Revised Guidelines on Similar Biologics- Regulatory requirements for Marketing Authorization in India, 2025'
Learn MoreJanuary 2025
WHO points to consider in continuous manufacturing of pharmaceutical products [Draft working document for comments]
Learn MoreDecember 2024
USFDA draft guidance: Expedited Program for Serious Conditions — Accelerated Approval of Drugs and Biologics Accelerated approval: one of FDA’s expedited programs intended to facilitate & expedite development and review of new drugs to address unmet medical need in treatment of life-threatening condition. Purpose of this guidance: provides information on FDA’s policies and procedures for accelerated approval & threshold criteria generally applicable to concluding that a drug is a candidate for accelerated approval. It also describes procedures for expedited withdrawal of approval of a product approved under accelerated approval
Learn MoreAs per ICH, impurity is “any component of the new drug substance which is not the chemical entity defined as the new drug substance”.Impurities are inevitable & will exist in small amounts.Guidelines set by agencies allow permissible limits to these impurities in order to bring pharmaceuticals into the market.The presentation discusses EDQM approach to 'Control of impurities'.
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