![]() ![]() Certification may be shown by marks on the product, container, or entry documents or by other paper or electronic communication. Such agreements should be designed with the intent of reducing the FDA rate of inspection or sampling that would otherwise be necessary and with the intent of providing a basis for assurance that the consumer protection objectives of FDA are being met. They may identify controls to be employed by the exporting country to assure the validity and reliability of certification. However, they may also involve products with a good compliance history (see Attachment A of this CPG). Historically, these MOU's have concerned products exported to the United States with inherent or consistent quality or safety problems. MOU's may establish certification criteria for products regulated by FDA. Under another form of such agreements, FDA and another country may agree that their regulatory systems governing certain products are the same or similar and are designed to provide the needed level of protection, enabling each country to consider reducing the rate of inspection or sampling of imports from the other country that would otherwise be necessary. The MOU's now in place for the exchange of results of good manufacturing practices and good laboratory practices inspections are examples. Under one form of such agreements, mutual acceptance of data and information, such as analytical findings and inspection results, may ordinarily be considered adequate for regulatory decisions. FDA MOU's that provide for the mutual assessment of the comparability of a foreign regulatory system or measure are suitable when it can be determined that FDA's controls and the foreign regulatory authority's controls are comparable and are designed to provide the same level of protection. These MOU's are similar to mutual recognition agreements (MRA's), referred to in recent trade agreements, and include equivalence agreements. MOU's may provide for the mutual assessment of the comparability of specific FDA's programs or activities with those of a foreign regulatory authority. Reciprocal Agreements with Countries Having the Same or Similar Systems Because officials of sovereign nations have different approaches to regulation, FDA needs to maintain flexibility in its discussions with these officials. These categories are not mutually exclusive, and the concepts may be altered or combined as necessary. The three categories of MOU's described in the following paragraphs are merely examples. Attachment A to this Compliance Policy Guide (CPG) sets forth the agency's criteria for setting priorities for international MOU's. Further, MOU's, if negotiated and implemented properly, enhance FDA's ability to carry out its mission. MOU's promote harmonization of laws, regulations, and enforcement activities. The FDA International Harmonization Task Force recommended in December 1992 that guidance be developed that describes the agency's objectives and promotes uniformity in developing MOU's with foreign government agencies. ![]() ![]() The general principles herein may also be applicable to MOU's with international organizations. This guide sets forth policy for initiating, developing, and monitoring agreements such as memoranda of understanding (MOU's) between the Food and Drug Administration (FDA) and foreign governments. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |