Developments from the US Food and Drug Administration, European Medicines Agency, and other key regulatory bodies and news
from key trade associations.
Rockville, MD (July 25)—The US Food and Drug Administration's Nanotechnology Task Force released a report that recommends that the agency consider developing guidance for manufacturers
and taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology. The task force
was initiated by FDA Commissioner Andrew von Eschenbach in 2006.
The report addresses regulatory and scientific issues. The report outlines that nanoscale materials potentially could be used
in most product types regulated by FDA and that those materials present challenges similar to those posed by products using
other emerging technologies. The challenges, however, may be complicated by the fact that properties relevant to product
safety and effectiveness may change as size varies within the nanoscale.
The report recommends consideration of agency guidance that would clarify, for example, what information to give FDA about
products, and also when the use of nanoscale materials may change the regulatory status of particular products. As with other
FDA guidance, draft guidance documents would be made available for public comment before being finalized.
The report may be found here|~www.FLA.gov/nanotechnology/taskforce/report2007.pdf.
Rockville, MD (July 20)—The US Food and Drug Administration issued a draft guidance titled Cooperative Manufacturing Agreements for Licensed Biologics|~www.FdA.gov/OHRMS/DOCKETS/98fr/99d-2013-gdl0002.pdf. The guidance supersedes FDA's Policy Statement Concerning Cooperative Manufacturing Arrangements for Licensed Biologics, which was published in the Federal Register of Nov. 1992 (57 FR 55544) (Ref. 1), and revises the draft guidance of the same title, dated August 1999.
The draft guidance on cooperative manufacturing arrangements applies to biological products subject to licensure under section
351 of the Public Health Service Act (PHS Act) (42 USC 262). This document is issued jointly by the Center for Biologics Evaluation
and Research and the Center for Drug Evaluation and Research.
The draft guidance addresses several types of manufacturing arrangements (i.e., short-supply arrangements, divided-manufacturing
arrangements, shared-manufacturing arrangements, and contract-manufacturing arrangements) and describes certain reporting
and recordkeeping responsibilities associated with these arrangements for the licensed manufacturer(s), contract manufacturer(s),
and final product manufacturer(s). These responsibilities include: notification of any proposed change in the product, production
process, quality controls or facilities; notification of results of tests and investigations related to or impacting the product;
notification of products manufactured in a contract facility; and standard operating procedures.
Comments on the draft guidance are due Sept. 1, 2007. The draft guidance may be found here|~www.fda.gov/OHRMS/DOCKETS/98fr/99d-2013-gdl0002.pdf.
Rockville, MD (July 13)—The US Food and Drug Administration announced the International Conference on Harmonization (ICH) draft guidance Q10 Pharmaceutical Quality System in the Federal
Register (Docket 2007D-0266, CDER 200783).
The ICH Q10 draft guideline describes one approach for "an effective pharmaceutical quality system that is based on ISO concepts,
includes applicable good manufacturing practice regulations and complements ICH Q8 'Pharmaceutical Development' and Q9 'Quality
Risk Management.'" The guideline, which is optional, applies to pharmaceutical drug substances and drug products, including
biotechnology and biological products, throughout the product life cycle.
The document specifically outlines the "product life cycle" to include pharmaceutical development, technology transfer, manufacturing,
and product discontinuation. Among the areas discussed in the guideline are management responsibility (including planning,
management, communication, and review), continual improvement of process performance and product quality (including life cycle
stage goals), and continual improvement of the pharmaceutical quality system (including monitoring internal and external impact
The draft guideline|~www.fda.gov/OHRMS/DOCKETS/98fr/07d-0266-gdl0001.pdf is open for public comment until Oct. 11, 2007.
Rockville, MD (July 9)—A new guidance issued by the US Food and Drug Administration advises companies about how to treat polymorphic drug compounds—those that exhibit multiple structural forms—when filing
abbreviated new drug applications. The bottom line, according to the guidance, is that generic drug products containing the
polymorphs be the "same" as the reference listed drug in active ingredients, bioavailability, and bioequivalence. The guidance
pertains to orally available drugs that are either solid- or suspension-dosage products.