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EMA ICH Q3D Workshop

EMA announced a workshop it will be conducting on “ICH Q3D from a quality perspective,” on April 5-6, 2016, at its headquarters in London. Participants will include EU regulators, the European Pharmacopoeia and the pharmaceutical industry. The workshop will focus “mainly on the quality aspects of the guideline and its implementation in the European regulatory […]

IPQ Monthly Update — November/December 2015 in Review

With the ICH Q12 initiative operating as a catalyst, the dialogue has been intensifying on what is needed to make quality regulatory processes across the product lifecycle more coherent, efficient, process improvement and product supply friendly, and internationally harmonized. This IPQ Monthly Update departs from the usual format to provide a series of stories exploring the various dimensions of the lifecycle management regulatory challenge and the international effort to better address it....

ICH’s API Coverage Deepening with a Newly Released Q&A on Q7 and a Q11 Q&A Project on Starting Materials Underway

A newly released Q&A from ICH on its active pharmaceutical ingredient (API) GMP guideline Q7 and another Q&A being prepared on the more recently issued API development and submission guideline Q11 are intended to address issues that have surfaced in implementing the two guidelines and drive more uniform interpretation across industry and regulators worldwide....

EC Draft on Sodium-Containing Excipients

The European Commission (EC) released a draft revision of the “Excipients in the label and package leaflet of medicinal products for human use” (CPMP/463/00 Rev. 1) annex covering the use of sodium-containing excipients. The nine-page draft, in the form of a Q&A document, was released in late June for a three-month public consultation. The Q&A […]

MHRA Business Plan

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) 2015/16 business plan was published at the end of June. Key strategic activities for 2015-16 include: ● bringing innovation and new products speedily and safely to patients ● strengthening surveillance ● ensuring safe medicines and devices and secure supply in globalized industries, and ● achieving a […]

FDA Guidance on Cell-Based Products for Animal Use

FDA has released a guidance on “Cell-Based Products for Animal Use.” It describes the current thinking at the Center for Veterinary Medicine (CVM) on the development, manufacturing, and marketing of cell-based products for animal use that meet the definition of a new animal drug.

FDA Established Conditions Draft Guidance

FDA released a draft guidance on “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” on June 1 for a 60-day comment period. The Federal Register notice states that the guidance was developed to address the “lack of clarity” with respect to what CMC information in a marketing application constitutes an “established condition” […]

FDA CMC Reviewer Recommendations for New Drug Approval Depend on Control Strategy Understanding, CDER is Stressing

CDER is stressing that a clear picture of the control strategy is pivotal for CMC reviewers to make a meaningful application approval recommendation and meet the shrinking timelines under which they are operating....

Novel Excipient Enables Successful MannKind Inhaled Insulin Formulation; Formulation/Device Inhalation Technology Offers Platform Potential

The development, testing, and use of a novel excipient as part of its formulation enabled MannKind to develop a viable inhaled insulin product after other firms’ insulin inhalation projects had not been successful....

India State Approval Times

India’s largest state, Maharashtra, has cut the time its FDA takes to process manufacturing licensing applications and “slashed” its backlog by adopting an online system, The Asian Age reported in early April. Over the six months the agency has used the system, it says that it has cleared 15,000 applications. Maharashtra’s FDA has implemented an […]
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