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Laws & Regulations - Drugs - Provisions for Supervising Preparing of Pharmaceutical Preparations in Medical Institutions (for trial implementation)
Provisions for Supervising Preparing of Pharmaceutical Preparations in Medical Institutions (for trial implementation)
 
2012/3/20 14:31:44¡¡Source: ¡¡Hits:

Chapter 1 General Provisions
Article 1 The Provisions are formulated for the purpose of strengthening supervision on preparing pharmaceutical preparations in medical institutions in accordance with the Drug Administration Law of the People¡¯s Republic of China (hereinafter referred to as the Drug Administration Law) and the Regulations for Implementation of the Drug Administration Law of the People¡¯s Republic of China (hereinafter referred to as the Regulations for Implementation of the Drug Administration Law).
Article 2 The Provisions apply to the preparing of pharmaceutical preparations in medical institutions and supervision on the preparing.
Article 3 Supervision on the preparing of pharmaceutical preparations in medical institutions refers to supervision activities of examination, permission and inspection on the conditions and process of preparing pharmaceutical preparations in medical institutions, which are conducted by (food and) drug regulatory departments in accordance with law.
Article 4 The State Food and Drug Administration is responsible for supervision on preparing pharmaceutical preparations in medical institutions nationwide.
The (Food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for supervision on the preparing of pharmaceutical preparations in medical institutions within their respective jurisdiction.
Article 5 Medical institutions shall comply with the Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions when preparing pharmaceutical preparations.

Chapter 2 Licensing of Establishment of Pharmaceutical Preparation Laboratory in Medical Institutions
Article 6 For preparing pharmaceutical preparations, a medical institution must have the staff, facilities, testing instruments, sanitary conditions and management systems to ensure the quality of pharmaceutical preparations.
Article 7 To establish a pharmaceutical preparation laboratory, a medical institution shall submit the following materials to the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, where the medical institution is located.
(1) Application Form for Pharmaceutical Preparation Certificate for Medical Institution (see appendix 1);
(2) Report on conducting self-testing in line with the Good Preparing Practice for Pharmaceutical Preparations in Medical Institutions;
(3) General information about the medical institution and photocopies of the duplicate of the Practicing License of Medical Institution;
(4) Consent of the local health administrative department of the province, autonomous region or municipality directly under the Central Government;
(5) General information about the pharmaceutical preparation laboratory to be established, including conditions such as the investment size, area, surrounding environment and infrastructure of the pharmaceutical preparation laboratory, master plan of the medical institution and master plan of the pharmaceutical preparation laboratory (air cleanliness class shall be marked);
Resumes of the person in charge of the pharmaceutical preparation laboratory, person in charge of the testing laboratory and person in charge of organizing quality management for pharmaceutical preparations (including their name, age, sex, academic qualification, major, position, professional title and number of years of work experience in medicine) and the proportion of technical personnel to the staff of the pharmaceutical preparation work;
The person in charge of the pharmaceutical preparation laboratory, person in charge of the testing laboratory and person in charge of organizing quality management for pharmaceutical preparations shall be on-the-job professionals of the institution, and the person in charge of the pharmaceutical preparation laboratory and the person in charge of the testing laboratory may not be the same one concurrently.
 (6) Dosage forms to be formulated, preparation capability, variety and specification;
(7) Process flow chart and quality specifications (or draft) of the dosage form (to be) formulated;
(8) List of main preparation equipment and testing instruments;
(9) List of preparation management and quality management documents.
Article 8 The applicant shall be responsible for the authenticity of the application dossier.
Article 9 After the application is received, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall handle the application respectively according to the following circumstances:
(1) Where an application item is not subject to the jurisdiction of the concerned department by law£¬the department shall immediately decide not to accept the application and inform the applicant to file the application with relevant administrative authorities;
(2) Where in the dossier there is an error that can be corrected on-site, on-site correction by the applicant shall be allowed;
(3) Where the dossier is incomplete or not conformed with the requirements of preliminary review£¬the applicant shall be given an one-off Notice for Supplementary Data or Correction, specifying all contents to be added or corrected, on site or within five days. If the applicant is not informed within the timeline, the application is regarded as accepted on the date the dossier is received.
(4) If the application dossier is complete and in compliance with the requirements of preliminary review or the applicant has submitted all the required supplementary or corrected data, the application of drug registration shall be accepted.
Where the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government accepts or rejects the application for Pharmaceutical Preparation Certificate for Medical Institution, it shall issue a dated Acceptance Notice or Non-Acceptance Notice with its seal for acceptance.
Article 10 The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, within 30 working days from the date the application is received, organize acceptance inspection according to the Acceptance Standard for Pharmaceutical Preparation Certificate for Medical Institution formulated by the State Food and Drug Administration. If the application passes the acceptance inspection, the department shall approve it and issue the Pharmaceutical Preparation Certificate for Medical Institution to the applicant within 10 working days from the date the approval decision is made; if the application fails the acceptance inspection, the department shall make a disapproval decision, notify the applicant in writing with the reasons thereof, and inform the applicant of the right to apply for administrative reconsideration or to bring an administrative suit by law.
For the application passing the acceptance inspection, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, within 20 working days from the date the Pharmaceutical Preparation Certificate for Medical Institution is granted, submit relevant information to the State Food and Drug Administration for the record.
Article 11 The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall publicize at the workplace the items, basis, conditions and timeline for application for the Pharmaceutical Preparation Certificate for Medical Institution, list of all the data needed to be submitted and model text of the application form.
The (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall give publicity to the decision of issuing the Pharmaceutical Preparation Certificate for Medical Institution , which the general public is entitled to consult
Article 12 When examining the application for establishment of a pharmaceutical preparation laboratory in a medical institution, the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall publicize the process a

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