Guidance Notes on the Application for Certificate for Clinical Trial and Medicinal Test

Transcription

1 Guidance Notes on the Application for Certificate for Clinical Trial and Medicinal Test According to section 129 of the Chinese Medicine Ordinance (Cap. 549), for the purpose of facilitating the conduct of a clinical trial or medicinal test of any proprietary Chinese medicine in Hong Kong, the Chinese Medicines Board ( CMB ) may, upon application, issue a certificate for clinical trial and medicinal test. (1) How to obtain application forms Application forms for the certificate for clinical trial and medicinal test are available a. by visiting the Chinese Medicines Section under the Chinese Medicine Division of the Department of Health ( DH ) during office hours: Address: 16/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon Office hours: Monday to Friday 9:00 a.m. to 5:30 p.m. Saturday, Sunday and Public Holidays Close b. by downloading from the homepage of the Chinese Medicine Council of Hong Kong (website: 1/6

2 (2) How to return application forms Applicants should return the duly completed application form, application fee and the documents required (see Annex) in the following ways a. by mail to the Chinese Medicines Section of the DH; or b. by submitting in person at the Chinese Medicines Section of the DH during office hours. Payment of application fee (HK$2,440) for a certificate for clinical trial and medicinal test should be made by a crossed cheque or bank draft made payable to The Government of the Hong Kong Special Administrative Region or The Government of the HKSAR with the personal or company name of the applicant written on the back of the cheque or bank draft. Please do not send cash by post. The application fee will not be refunded whether the application is approved or not. (3) Issue of Acknowledgement letter The Chinese Medicines Section of the DH will issue an acknowledgement letter to the applicant upon receipt of an application form, confirming that the application is under process. The acknowledgement letter will contain an application number and the applicant may quote this number when making an enquiry. (4) Application results If the application is approved by the CMB, the applicant will be notified in writing. Upon payment for the issue of the certificate, the Chinese Medicines Section of the DH will issue the certificate for clinical trial and medicinal test by registered post. The 2/6

3 applicant can also collect the certificate in person at the DH. Payment for the issue of a certificate for clinical trial and medicinal test (HK$79) should be made by a crossed cheque or bank draft made payable to The Government of the Hong Kong Special Administrative Region or The Government of the HKSAR with the application number written on the back of the cheque or bank draft. Please do not send cash by post. If the application is refused by the CMB, the applicant will also receive a notification setting out the reasons for refusal. (5) Amendment(s) to submitted information Should there be any change related to the applicant or submitted information during the evaluation of the application by the CMB, please inform the Chinese Medicines Section of the DH in writing by post or fax as soon as possible. (6) Enquires Should applicants have any enquires on the contents of this Guidance Notes, please contact the Chinese Medicines Section of the DH by phone or by fax: Enquiry hotline: Fax no: May /6

4 Annex Information and Documents to Be Submitted When Applying for Certificate for Clinical Trial and Medicinal Test Applicants are required to submit the following information and documents if the application for this certificate is made for conducting a medicinal test: 1. A completed application form, checklist for certificate for clinical trial and medicinal test application 2. A letter from the principal investigator confirming his involvement in the medicinal test concerned 3. The Curriculum Vitae of the principal investigator 4. A copy of the proposed medicinal test protocol 5. If the experiment is to be performed on a living vertebrate animal and calculated to give pain, the applicant is required to provide a copy of the Licence to Conduct Experiment issued under the Animals (Control of Experiments) Ordinance (Cap. 340) 6. A copy of the master formula of the proprietary Chinese medicine 7. A Sample of the proprietary Chinese medicine Applicants are required to submit the following information and documents if the application for this certificate is made for conducting a clinical trial : 1. A completed application form, checklist for certificate for clinical trial and medicinal test application 2. A copy of the proposed clinical trial protocol 3. A copy of the proposed Chinese or Chinese-English bilingual information(s) and informed consent form to be provided for the trial subjects 4. A letter from the principal investigator confirming his involvement in the clinical trial concerned 5. The Curriculum Vitae of the principal investigator and a copy of relevant certificate of registration 4/6

5 6. A letter from the Chinese medicine practitioner participating in the clinical trial confirming his involvement in the clinical trial concerned and a copy of his certificate of registration (there is no need to submit if the Chinese medicine practitioner is the principal investigator) 7. Letter of approval by the Ethics Committee of the institution at which the trial is to be conducted (may be submitted within 3 months from the date of application) 8. Investigator s brochure 9. The following documents and product of the related proprietary Chinese medicine: (i) Its master formula (ii) Information on pharmacological and toxicological studies (such as principal pharmacodynamic studies report, general pharmacological studies report, acute and long-term toxicity test report, etc.). If applicants do not submit animal testing reports, they have to provide good reasons for it. (iii) Manufacturing method (iv) Drafting note of product specification, product specification, method and certificate of analysis (v) Stability test report(s) (such as accelerated stability test, for the initial assessment of its preliminary stability). The stability tests should be conducted by manufacturers that comply with the requirements of GMP or by laboratories that comply with the requirements of the Chinese Medicines Board. (vi) Heavy metals and toxic elements, pesticide residues and microbial limit test reports (vii) A Sample of the proprietary Chinese medicine 10. Documents proving all the manufacturers involved in the production of the proprietary Chinese medicine comply with Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines (GMP) or equivalent (such as a copy of the manufacturer s GMP Certificate) 11. Documentary proof and information regarding the clinical trial(s) (if any) for the proprietary Chinese medicine conducting/conducted in its country of origin and other countries or regions The following information should be attached if the study is also approved by China Food and Drug Administration (CFDA): 5/6

6 (i) A copy of the drug clinical trial approval document ( 藥物臨床研究批件 ) or relevant documentary proof issued by the CFDA (may be submitted within 3 months from the date of application) (ii) A copy of the clinical trial protocol submitted to the CFDA Apart from the documents and information stated above, the Chinese Medicines Board may ask the applicant to provide other document(s), or the original copy of any submitted document(s) for verification if deemed necessary. May /6