The FDA has recently released a proposal for a new program aimed at recognizing voluntary consensus standards for pharmaceutical quality. The purpose of the standards is to streamline the review of marketing applications for pharmaceuticals and to promote innovation in drug development.
Under the planned program, FDA regulators, industry representatives, members of academia, and other interested groups will be able to propose new pharmaceutical quality standards for review and possible adoption by the FDA. The idea is to make the development process for drugs more efficient.
The program should enable the FDA to more efficiently evaluate the information from drug product applications and accelerate their development. The standards will also give clearer guidelines for manufacturers, reducing uncertainty in the regulatory process, thereby enabling them to be more innovative as well.
The transparency and clarity provided by such quality standards, both pre- and post-market, will increase the overall efficiency in the development and manufacturing process for drugs. Such provisions will also enable manufacturers to focus more on development methods and acceptance criteria, according to FDA officials.
The FDA will use the following criteria in developing the voluntary consensus standards:
- The processes and procedures used to determine who can participate in their development must be open and transparent. Interested parties must be given opportunities to contribute without discrimination.
- There should be a broad range of input from various concerned groups in developing the standards, and no one interest should dominate the process.
- The development of the standards should follow due process, where development policies are advertised, interested groups are given notice of meetings and activities with opportunities to review proposals and register objections, and there is a fair and impartial process for resolving conflicts.
When the list of consensus standards is finalized, it will appear on the FDA’s website, available for anyone in the pharmaceutical industry to consult when putting together information for applications. Each standard will include information about the address where the standard can be obtained, the scope and extent of the FDA’s recognition of the standard and the date of recognition of the standard.
These new standards are voluntary and not related to other provisions already in effect under the Federal Food, Drug and Cosmetic Act.
The consensus standards are expected to have a significant impact in the area of generic and biosimilar drug manufacturing because the standards are expected to streamline the development of these drugs, enabling companies to get them on the market more quickly and provide alternatives for brand name drugs.
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