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Advanced Therapy Classification System on Regulatory Front Burner in Europe as Product Wave Builds Globally

As the wave of highly diverse cell/tissue/gene therapies under development continues to build globally, establishing a viable and mutually agreed upon classification system has become a top regulatory priority....

APIC is Mapping API Requirements in Emerging Countries and Working with Them to Create More Transparent, Efficient, and Harmonized Regulatory Processes

The Europe-based Active Pharmaceutical Ingredients Council (APIC) is mapping out the current API registration requirements in emerging countries, defining best practices, and developing strategies for working with the various authorities on creating more transparent, efficient and harmonized regulatory processes....

FDA Criteria for “First Generic” ANDA

In the Federal Register in mid-November, FDA proposed a common definition for “first generic” in order to clarify the agency’s prioritization of ANDA approvals. A MAPP from August 2014 stated that the review of ANDAs that are “first to file” would receive prioritization, but did not provide a distinct definition. The Federal Register states that […]

IPEC Library of Nanotech Information

IPEC-Americas has made available to its members a “Library of Nanotechnology Information.” The library contains articles on safety/toxicology and regulatory information regarding nanotech. IPEC, in turn, asked its membership for feedback on: acceptable uses of nanomaterials, physicochemical properties used in describing nanomaterials, toxicity concerns, safety of human exposure, and descriptions of the regulatory environment for […]

FDA on Removing Duplicative BLA Requirements

In mid-August, FDA issued a proposed rule on removing §§ 610.11, 610.11a, and 680.3(b) – regulations that require manufacturers of biological products to perform a specified test for general safety of biological products. FDA explained in its Federal Register announcement that these regulations are “duplicative, outmoded, or are otherwise unnecessary” in assuring safety, purity, and […]

Comment Period Reopened During July on OTC Monograph System

FDA reopened the comment period on the functioning of the OTC monograph system during July to allow new and updated information to be submitted. A public hearing on the monograph system was held in March 2014.

IPEC and IQ Consortium Team Up to Push for an Independent Pathway for New Excipient Review

A call to action is reverberating through the pharmaceutical community for the establishment of a viable regulatory pathway for new or modified excipients, which would empower industry to develop more quality-by-design-based formulations....

FDA Releases Final Guidance on Expedited Drug Approval Pathways

In late May, FDA released a final guidance for industry on expedited programs for serious conditions, which reflects comments that came in on the draft released in June 2013 (See IPQ Sept. 16, 2013 and Sept. 26, 2013). The guidance acts as a single resource for policies and procedures related to the four FDA programs […]

China’s FDA Voices Interest in Developing an Excipient DMF System at Meeting with IPEC China; India Among Countries Reviewing Excipient Regulatory Upgrades

China is among countries giving consideration to establishing a drug master file (DMF) system for excipients, as regulators world-wide seek to rationalize and improve their approaches to excipient oversight....

MHRA Announces “Early Access to Medicines Scheme”

In early April, MHRA announced its fast-track pathway for drug approval, known as the “Early Access to Medicines Scheme” (EAMS), which “aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need.” The MHRA notice came […]
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