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INTERVIEW #SpeakPharma

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Expert Take on CEP 2.0: A New Era of Transparency in Pharmaceutical Regulation

At the recent EDQM conference “Certified for Success: Using the CEP Procedure to Elevate Quality and Drive Trust,” regulatory leaders gathered to discuss one of the most significant shifts in European pharmaceutical oversight recently– the transition to CEP 2.0. In the following article, Karina Boszko, Head of Global Regulatory Affairs and Customer Technical Service at Polpharma API, shares her perspective on the new framework and its impact on transforming regulatory strategies for manufacturers worldwide. A strategic shift beyond just compliance. CEP 2.0 is more than a routine update. It represents a fundamental change in how pharmaceutical companies approach transparency, lifecycle management, and international expansion. Rather than focusing solely on documentation, the framework encourages organizations to treat regulatory excellence as a strategic differentiator, shifting the mindset from static compliance to continuous lifecycle oversight. Regulatory alignment thus becomes a living process that evolves with the product, data, and technology. Embedding this approach across teams will foster a culture of iterative improvement, innovation, and stronger organizational resilience. For many manufacturers, however, this will require introducing significant internal changes, from documentation practices to cross-functional collaboration. CEP 2.0 means faster timelines and higher predictability. But only if your team is ready. One of the most anticipated benefits of CEP 2.0 is more predictable review timelines and consistent submissions. However, leveraging these advantages depends heavily on industry readiness. Regulatory teams must adapt to more streamlined, data-driven processes and ensure that digital tools, training, and workflows support accelerated operations. Organizations that modernize will see multiple operational benefits early, including faster project completion, reduced rework, and quicker access to key markets as standardized documentation and cohesive global expectations will make previously complex or "slow” markets more accessible. For companies pursuing international expansion, CEP 2.0 provides a clearer path to global approvals, cross-market consistency, and enhanced competitiveness. Balancing challenges with opportunity. Despite its promise, the transition to CEP 2.0 is not without challenges. Data privacy, operational costs, supply chain complexity, and pressure on low-margin APIs remain key industry concerns that require striking a balance between stringent compliance and long-term sustainability. Still, companies that efficiently integrate regulatory requirements into scalable operations will not only demonstrate the maturity of their quality systems but also build trust externally, strengthening their reputation and differentiating their business in an increasingly competitive market. Looking ahead to a more collaborative future. CEP 2.0 positions the pharmaceutical sector for a future where regulatory excellence drives global competitiveness. Transparency, harmonization, and a lifecycle approach will increasingly define market leaders. The framework’s success, however, requires ongoing dialogue with regulators. Clear, practical guidance from the EDQM, combined with active feedback from manufacturers, is essential. The more open the collaboration, the more effectively CEP 2.0 will support innovation, quality, and patient safety. The question for every organization is how to approach this moment: as a compliance burden, or as a strategic opportunity to elevate quality, accelerate growth, and build long-term trust. Connect with Polpharma API: Your Partner in Pharma AdvancementFor more information on how Polpharma API can be your strategic ally in drug substance development and manufacturing, contact us at api@polpharma.comLet's embark on a journey of innovation and excellence together.

Impressions: 253

VLOG #PharmaReel

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Expertise in Particle Size Engineering

This PharmaReel highlights Munit SA, a leading player with over 60 years of expertise in Micronization, Milling, and HPAPI Handling. By enhancing solubility and bioavailability, Munit SA delivers innovative pharmaceutical solutions that meet the highest industry standards. Certified by the FDA, PMDA, MHRA, MFDS, and other global authorities, Munit SA ensures excellence and compliance in every micronization process.

Impressions: 146

DATA COMPILATION #PharmaFlow

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FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

This week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs (OPOE) without an approved generic. The OPOE list gets updated every six months.This list highlights drug products that have lost patent protection and regulatory exclusivity, but remain without approved generic competition in the US market. With this list, the FDA hopes to bolster competitiveness in the generics market, improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since December 2021, FDA has been publishing two versions of the OPOE list — one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 296 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The increase in drug products from 765 to 784 from June 2025 to December 2025 was due to the inclusion of additional dosage strengths in the OPOE Rx list. Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation), pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of ANDAs that aims to encourage and reward investment in drug manufacturing, research and development and strengthen the pharmaceutical supply chain in the United States.Separately, FDA has also come out with a new draft guidance that seeks to simplify biosimilarity studies and reduce unnecessary clinical testing. Through a separate initiative, the agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, thereby helping patients and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of 5.04 percent from 2025 to 2034. With several diabetes, immunology, oncology and cardiology drugs slated to face patent expirations this year, and continued pressure on drugmakers to improve affordability, we believe the generic market could grow at an even faster rate in the near term.

Impressions: 1780

NEWS #PharmaBuzz

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Enforcement Report - Week of April 23, 2025

23 Apr 2025

// FDA

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