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The announcement of CFDA will effect a large collection of pharmaceutical companies

2019-04-29

On April 28th, CFDA released “an announcement on cancelling to provide 36 items of documents (NO.34 file of 2019)”that will effect a large collection of pharmaceutical companies.

      According to the official website of the State Food and Drug Administration: in accordance with the requirements of the Notice of the General Office of the State Council on Cleaning Up Certification Matters (Guo Ban Fa [2018] No. 47), in order to further reduce the number of certificates for convenience and optimize services, the State Medical Products Administration has decided to cancel 36 certification items (see annex for details), which are hereby released. From the date of issuance, the implementation of the certification matters specified in the regulatory documents listed in the annex shall cease. Where the certification matters set forth in the departmental rules listed in the Annex involve the revision of departmental rules, enforcement shall be suspended after the departmental rules are amended in accordance with the procedures.

       The 36 certification items include: 22 "certification matters set by departmental rules" and 14 "certification matters set by normative documents", involving drug production licenses, licensed pharmacist registration certificates and many other aspects, most of which are no longer required to be submitted by applicants. It will bring greater convenience to the operation of pharmaceutical production, wholesale and retail enterprises.
       The list of matters is as follows:

Annex 1: Cancelled departmental regulationsPrescribed certification items (22 items)

serial number	provefile	use	Basis	After cancellation How to handle it
serial number	provefile	use	Basis	After cancellation How to handle it
1	Drug production license	Supplementary drug application: 1. Apply for changing the packaging material or container that directly contacts the drug 2. Apply for changing the expiration date of the domestically produced drug 3. Apply for changing the origin of the raw material drug of the domestically produced drug preparation 4. Apply for changing the name of the domestic drug manufacturer 5. Apply for internal Change of drug production site 6. Apply for change of packaging specifications of domestically produced drugs 7. Apply for change of packaging labels of domestically produced drugs 8. Apply for supplementation and improvement of safety content of domestically produced drug insert sheets 9. Apply for revision of domestically produced drug insert sheets 10. Apply for changes in domestically produced drugs Appearance, but do not change drug standards 11. Apply for revision of domestically produced drug instructions	Article 114, Article 115, Annex 4 of the Measures for the Administration of Drug Registration	Applicants are no longer required to submit this matter and are subject to online verification
2	Good Manufacturing Practice Certification Certificate			Applicants are no longer required to submit this matter and are subject to online verification
3	Drug production license	Domestic drug re-registration approval	Article 122 of the "Measures for the Administration of Drug Registration", Annex 5: 1. Domestic production of drugs	Applicants are no longer required to submit this matter and are subject to online verification
4	Good Manufacturing Practice Certification Certificate	Domestic drug re-registration approval		Applicants are no longer required to submit this matter and are subject to online verification
5	Drug production license	Drug entrusted production approval	Article 33 of the "Measures for the Supervision and Administration of Drug Production"	Applicants are no longer required to submit this matter and are subject to online verification
6	Licensed Pharmacist Registration Certificate	Drug wholesale and retail enterprise license	Articles 8 and 9 of "Administrative Measures for Drug Distribution License"	Applicants are no longer required to submit this matter and are subject to online verification
7	No outstanding case certificate	Application for change of drug business license	Article 16 of the "Measures for the Administration of Drug Distribution Licenses"	Applicants are no longer required to submit this matter, but instead informed of the commitment
8	There is no proof of circumstances stipulated in Article 75 and Article 82 of the Drug Administration Law	Pharmaceutical wholesale enterprises apply for a pharmaceutical business license	Article 4 of the "Measures for the Administration of Drug Distribution Licenses"	Applicants are no longer required to submit this matter, but instead informed of the commitment
9	There is no proof of circumstances stipulated in Article 75 and Article 82 of the Drug Administration Law	Drug retail enterprises apply for a drug business license	Article 5 of the "Measures for the Administration of Drug Distribution Licenses"	Applicants are no longer required to submit this matter, but instead informed of the commitment
10	Drug production license	Import filing of raw materials and preparation intermediates required by pharmaceutical manufacturers	Article 13 of the "Measures for the Administration of Drug Import"	Applicants are no longer required to submit this matter and are subject to online verification
11	Drug production license	Approval for the export of anabolic agents and peptide hormones	Article 15 of the "Administrative Measures for the Import and Export of Anabolic Agents and Peptide Hormones"	Applicants are no longer required to submit this matter and are subject to online verification
12	Drug production license	Approval for the production of pharmaceutical precursor chemicals in the first category	Article 6 of the "Administrative Measures for Precursor Chemicals of Drugs"	Applicants are no longer required to submit this matter and are subject to online verification
13	Good Manufacturing Practice Certification Certificate			Applicants are no longer required to submit this matter and are subject to online verification
14	Drug production license	Approval for the purchase of pharmaceutical precursor chemicals in the first category	Article 18, Annex 7 of the Measures for the Administration of Pharmaceutical Precursor Chemicals	Applicants are no longer required to submit this matter and are subject to online verification
15	Good Manufacturing Practice Certification Certificate			Applicants are no longer required to submit this matter and are subject to online verification
16	Good Manufacturing Practice Certification Certificate	Declaration of the transfer and use of preparations by medical institutions	Annex 2 of the Administrative Measures for the Registration of Preparations by Medical Institutions (for Trial Implementation).	Applicants are no longer required to submit this matter and are subject to online verification
17	Good Manufacturing Practice Certification Certificate	Application for supplementary preparation by medical institutions (preparation by entrusted drug manufacturers)	Article 30 of the Measures for the Administration of Preparations Registration of Medical Institutions, Annex Catalogue: II. Explanation	Applicants are no longer required to submit this matter and are subject to online verification
18	Drug production license	Preparation license for medical institutions (consignment of preparation by pharmaceutical manufacturers)	Article 33 of the Measures for the Supervision and Administration of the Preparation of Preparations by Medical Institutions (for Trial Implementation).	Applicants are no longer required to submit this matter and are subject to online verification
19	Good Manufacturing Practice Certification Certificate			Applicants are no longer required to submit this matter and are subject to online verification
20	The previous approved medical institution's commissioned preparation of traditional Chinese medicine preparations	Medical institution preparation license (application for renewal of commissioned preparation)	Article 33 of the Measures for the Supervision and Administration of the Preparation of Preparations by Medical Institutions (for Trial Implementation).	Applicants are no longer required to submit this matter and are subject to internal verification
21	Internet drug information service qualification certificate	Medical device online sales information filing	Articles 8 and 9 of the Measures for the Supervision and Administration of Online Sales of Medical Devices	Applicants are no longer required to submit this matter and are subject to online verification
22	Loss of Statement	Apply for the reissuance of lost drug production licenses	Article 21 of the Measures for the Supervision and Administration of Drug Production	Applicants are no longer required to submit this matter, but instead informed of the commitment
		Apply for the reissuance of domestic Class II and Class III medical device production licenses for lost use	Article 19 of the Measures for the Supervision and Administration of Medical Device Production
		Apply for the reissuance of a lost medical device business license	Article 24 of the Measures for the Supervision and Administration of Medical Device Operations

Annex 2: Matters to prove the establishment of canceled normative documents (12 items)

serial number	provefile	use	Basis	After cancellation How to handle it
1	Drug production license	Registration and approval of imported drugs (one-time import by drug R&D institutions or pharmaceutical manufacturers)	Announcement on Matters Related to the One-time Import of Reference Drugs for Research Required in the Development Process (Announcement of the State Food and Drug Administration No. 120 of 2016) 1. Scope of application, 3. Requirements for declaration materials	Applicants are no longer required to submit this matter and are subject to online verification
2	Drug production license	The production and use of traditional Chinese medicine extracts are recorded	Articles 4 and 5 of the Notice of the CFDA on Strengthening the Supervision and Administration of Extracts and Extracts in the Production of Traditional Chinese Medicines (CFDA [2014] No. 135).	Applicants are no longer required to submit this matter and are subject to online verification
3	Good Manufacturing Practice Certification Certificate			Applicants are no longer required to submit this matter and are subject to online verification
4	Drug production license	Recordation of drug commissioned production (entrusted by overseas pharmaceutical manufacturers)	Article 7 of the Administrative Provisions on the Recordation of Drugs Entrusted by Overseas Pharmaceutical Manufacturers (Guo Food and Drug Administration [2005] No. 541).	Applicants are no longer required to submit this matter and are subject to online verification
5	Good Manufacturing Practice Certification Certificate
6	There is no certificate of illegal distribution of fake and inferior drugs	Pharmaceutical trading enterprises apply for the certification of good management practices for drug trading	Article 18 of the Administrative Measures for the Certification of Good Management Standards for Drug Trading (Guo Food and Drug Administration [2003] No. 25).	Applicants are no longer required to submit this matter, but instead informed of the commitment
7	Drug production license	Issuance of postal certificates for narcotic drugs and psychotropic substances	Article 5 of the Measures for the Administration of Narcotic Drugs and Psychotropic Substances by Mail (Guo Food and Drug Administration [2005] No. 498).	Applicants are no longer required to submit this matter and are subject to online verification
8	Good Manufacturing Practice Certification Certificate
9	Drug production license	Issuance of certificates for the transport of narcotic drugs and Class I psychotropic substances	Article 4 of the Measures for the Administration of the Transport of Narcotic Drugs and Psychotropic Substances (Guo Food and Drug Administration [2005] No. 660).	Applicants are no longer required to submit this matter and are subject to online verification
10	Good Manufacturing Practice Certification Certificate
11	Review opinions on the production of sanitary conditions of domestic special purpose cosmetics	Approval of domestic special-purpose cosmetics	Annex to the Provisions on the Application and Acceptance of Administrative Licensing of Cosmetics (Guo Food and Drug Administration [2009] No. 856): Article 2 of the Requirements for Application Materials for Administrative Licensing of Cosmetics	Applicants are no longer required to submit this matter
12	Domestic special purpose cosmetics production, listing, supervision opinions or review opinions on the unmarketed products	Approval of domestic special-purpose cosmetics	Annex to the Provisions on the Application and Acceptance of Administrative Licensing of Cosmetics (Guo Food and Drug Administration [2009] No. 856): Article 9 of the Requirements for Application Materials for Administrative Licensing of Cosmetics	Applicants are no longer required to submit this matter
13	Loss of Statement	Apply for the reissuance of lost cosmetics production license	Article 24 of the Announcement on Matters Related to the Production License of Cosmetics (Announcement No. 265 of 2015 of the State Food and Drug Administration).	Applicants are no longer required to submit this matter, but instead informed of the commitment
14	Drug production license	Registration of licensed pharmacists practicing in pharmaceutical manufacturing enterprises (first time, change of registration)	Articles 9 and 16 of the Interim Measures for the Registration and Administration of Licensed Pharmacists (Guo Yao Guan Ren [2000] No. 156).	Applicants are no longer required to submit this matter and are subject to online verification