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EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment

EMA’s draft guideline on quality requirements for drug-device combination (DDC) products provides a template for the new concept of the notified body opinion (NBOp), intended to help ensure a consistent interpretation by individual assessors, notified bodies, and industry.

Refined Training, Project Selection, and Membership Processes Strengthen ICH’s Global Harmonization Efforts

Refined processes for training, project selection and membership are strengthening ICH’s ability to realize in practice the global harmonization objectives of its guideline development efforts, ICH leaders are affirming.

IPEC Digesting Implications of China’s Ending of Separate Excipient Approval Process

The International Pharmaceutical Excipients Council (IPEC) is working with its members and China’s Center for Drug Evaluation [CDE] to digest and manage the implications of the decision in China to switch from a separate approval process for pharmaceutical excipients to submission and review of an excipient dossier together with a drug application.

Diverging Regional Excipient Regulations Are Creating Problems for Excipient Manufacture, Distribution and Use Globally

A review of the way excipients are regulated by agencies around the world reveals that regional regulations continue to proliferate and the differences are creating problems for the manufacture, distribution and use of excipients globally. 

Novel Excipients, DMFs, and Atypical Actives Among Pressing Issues on IPEC-Americas’ Front Burner

Novel excipients, drug master files (DMFs), and atypical actives are among the pressing issues on which the International Pharmaceutical Excipients Council (IPEC) is actively engaged with the major regulatory agencies and standards organizations around the world.

Role of Established Conditions Drawing Attention in Global Dialogue on ICH Q12’S Potential

The interpretation and application of the approaches for determining established conditions (ECs) provided in the Step 2 draft of ICH Q12 and how these interface with regulatory reporting expectations is drawing particular attention as industry explores the opportunities that the ICH Q12 concepts present in practice.

Experience with In Vitro Fertilization Clinics Raises Strong Warnings on Cell Culture/Processing Air Purification

Experience with in vitro fertilization (IVF) clinics is sending a strong signal that applying significantly heightened air purification standards and more advanced technology to meet them may be critical across all cell culture/processing operations.

CMC Priorities of EFPIA’s European Biopharmaceutical Enterprises Include ADCs, Drug/Device Combos and Statistics

Drug device combinations (DDCs), antibody drug conjugates (ADCs), and the use of statistics in comparability assessments are among the current focal points of the European Biopharmaceutical Enterprises (EBE) in its efforts to identify and build consensus around the most pressing issues on the global regulatory agenda for biotech manufacturing and control.

Pharma is Exploring How to Maximize ICH Q12 Value in Practice; Q12 EWG Encourages Feedback

Pharmaceutical manufacturers are exploring how the ICH Q12 lifecycle management concepts can be implemented internally and in their interactions with regulators to maximize the benefits in practice.

Understanding Drug/Device Terminology Differences is Critical to Combination Product Control and Regulatory Communications, Industry Experts are Stressing

Industry experts are stressing that the payoff for combination products in understanding and bridging the drug/biologic/device terminology differences is a smoother development process, a simpler, more effective control system, and better communications with CMC reviewers and GMP inspectors.
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