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IPEC Continues to Urge Family Approach in Dialogue with FDA on Improving Inactive Ingredient Database

IPEC-Americas and the Generic Pharmaceutical Association (GPhA) are continuing their advocacy of FDA incorporating a family approach in the toxicology assessment of excipients as they work with the agency on further improving the inactive ingredient database (IID) to support better drug development and more efficient FDA reviews.

Culture and Process Capability Continue In Focus as FDA Releases Its Draft Quality Metrics Guidance

FDA is asking for industry input on how quality culture and process capability evaluations can contribute to the “baseline” metrics it has put on the table for review in its draft quality metrics guidance.

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.

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....

Biosimilar Interchangeability in Finland

The Finnish Medicines Agency (FIMEA) has recommended that the Finnish healthcare system allow physician-authorized switching of branded products and their biosimilars. The agency cited evidence in its four-page report that no adverse events have yet been reported when such patient switches occurred. A similar recommendation was made by the Netherlands’ Medicines Evaluation Board (MEB) earlier […]

EU Medicines Agencies Network Strategy to 2020

EMA and the Heads of Medicines Agencies (HMA) released the “EU Medicines Agencies Network Strategy to 2020” draft in late March. The network strategy draft is organized into four themes: ● human health ● animal health and human health related to veterinary medicines ● optimizing the operation of the network, and ● the global regulatory […]

New MHRA Compliance Report Guidance and Template

MHRA updated its compliance report guidance and the template for that report in mid-March. The report is now separated into a “Pre-Inspection Compliance Report” and an “Interim Compliance Report.”
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