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To implement the "opinions of the State Council on the reform of drug and medical device review and approval system" (Guo Fa 2015 No. 44), to simplify the drug approval process, packaging materials and containers will be in direct contact with drugs (hereinafter referred to as packaging materials), medicinal materials by a separate approval in the registration application for approval together with the review and approval of drugs. The relevant matters are hereby announced as follows:
First, in the territory of People's Republic of China development, production, import and use of packaging materials, medicinal materials, the application of this announcement requirements. Packaging materials, medicinal materials for imported drugs in accordance with the relevant provisions of the "measures" drug registration management implementation.
Two, the State Food and Drug Administration in accordance with the principles of risk management in the examination and approval of drug registration application of packaging materials, medicinal materials implement the related review and approval. The State Food and Drug Administration announced the development scope of packaging materials, medicinal materials to implement the related review and approval (see Annex 1), and according to the work need to adjust and perfect. Packaging materials, medicinal materials not included in the scope of review and approval of the association should conform to the requirements for medicinal use.
Three, since the date of this announcement, packaging materials, medicinal materials should be according to the procedure (see Annex 2) registration related reporting and review and approval and drug packaging materials and medicinal materials, "reporting requirements" to be announced. The food and drug supervision and management departments at all levels alone is no longer accepting the application packaging materials, pharmaceutical excipients registration, no longer separately issued by the relevant approval documents for registration.
Four, packaging materials, medicinal materials change prescription, technology and quality criteria affecting the quality of products is changed, the production enterprises should take the initiative to carry out the corresponding evaluation, timely notify the pharmaceutical production enterprises, and according to the requirements of the food and drug supervision and administration department shall submit the relevant materials. The relevant requirements of packaging materials, medicinal materials change shall be formulated by the State Food and drug administration.
Five, the approved packaging materials, medicinal materials, the approval documents continue in effect within the period of validity. After the expiry of the validity period, can continue to use in the original drug. In the application for clinical trials or production of other drugs, the relevant information shall be submitted in accordance with the requirements of this announcement.
A certificate of approval in December 31, 2017 (including the day) before the expiration of the packaging materials, medicinal materials, extended to December 31, 2017. Since January 1, 2018, when the application for clinical trials or production of other drugs, the relevant information should be submitted in accordance with the requirements of this announcement.
In the listed drug has been used in the history of other medical requirements in line with the requirements of medicinal materials, can continue to be used in the original drug. However, when applying for clinical trial application or production of other drugs, the relevant information shall be submitted in accordance with the requirements of this announcement.
Six, packaging materials, medicinal materials production enterprises should responsible for the quality of products; should meet the conditions corresponding to production quality management requirements of the organization should be carried out with the supplier audit production; pharmaceutical production enterprises.
Seven, the applicant for drug registration shall ensure the use of packaging materials, medicinal materials meet the requirements for medicinal use should be strengthened; packaging materials, medicinal materials supplier audit; should change timely grasp of packaging materials, medicinal materials, research and evaluation and the effect of the change, submit the corresponding supplementary application to the food and drug supervision and management departments in accordance with the "the relevant provisions for drug registration management measures" etc..
The food and drug supervision and management departments, eight packaging materials, medicinal materials production enterprises should be located within the administrative area of packaging materials, medicinal materials production enterprises into the scope of the daily supervision. The State Food and drug administration to conduct supervision and inspection on imported packaging materials, medicinal materials production enterprises.
Nine, this announcement shall come into force as of the date of promulgation. Had been accepted, drug packaging materials and medicinal materials for registration to review according to the original provisions for approval, after drugs, drug packaging materials and medicinal materials review and approval requirements inconsistent with this announcement, to the announcement.
Hereby announcement.