The News In Depth

IPQ Monthly Update – July/August 2018 in Review

The July/August issue begins with an exploration of how the ICH process has been evolving and the challenges and opportunities that are now presenting themselves. The second story then takes a deep dive into the intensive dialogue taking place on implementing ICH Q12 and its established conditions provisions, in particular. A series of three stories follows on the problems created by the different excipient regulatory frameworks and requirements around the world for both suppliers and users in their efforts to assure and improve the quality and availability of medicines.

October 1, 2018 | Posted in The News in Depth | Read More »

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.

September 6, 2018 | Posted in The News in Depth,Uncategorized | Read More »

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.

August 31, 2018 | Posted in The News in Depth,Uncategorized | Read More »

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.

August 30, 2018 | Posted in The News in Depth,Uncategorized | Read More »

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.

August 29, 2018 | Posted in The News in Depth,Uncategorized | Read More »

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.

August 13, 2018 | Posted in The News in Depth,Uncategorized | Read More »

IPQ Monthly Update – May/June 2018 in Review

The issue includes in-depth stories on: ● the intensive dialogue going on now in the wake of the emergence of an ICH Q12 Step 2b draft for public comment ● the role EFPIA’s European Biopharma Enterprises (EBE) is playing in identifying and building consensus around the most pressing issues on the global regulatory agenda for biotech manufacturing and control, and ● the experience at a leading in vitro fertilization (IVF) clinic in figuring out the cause of dramatic periodic declines in the clinic’s normal best-in-class success rates and what needed to be done to prevent them, including the development of much more powerful air purification technology.

August 6, 2018 | Posted in The News in Depth | Read More »

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.

July 16, 2018 | Posted in The News in Depth,Uncategorized | Read More »

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.

July 11, 2018 | Posted in The News in Depth,Uncategorized | Read More »

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.

July 3, 2018 | Posted in The News in Depth,Uncategorized | Read More »