1 / 78

ZHANG WEI Director General, Department of Drug Registration May 17, 2010, Beijing

Establishment and Implementation of Regulations and Policies on Drug Registration and Impacts on the Pharmaceutical Industry of China. ZHANG WEI Director General, Department of Drug Registration May 17, 2010, Beijing 2 nd DIA China Annual Meeting. Overview.

louis
Télécharger la présentation

ZHANG WEI Director General, Department of Drug Registration May 17, 2010, Beijing

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Establishment and Implementation of Regulations and Policies on Drug Registration and Impacts on the Pharmaceutical Industry of China ZHANG WEI Director General, Department of Drug Registration May 17, 2010, Beijing 2nd DIA China Annual Meeting

  2. Overview • Progress on the Laws and Regulations concerning Drug Registration in 2009 • Major Measures adopted on Drug Registration in 2009 • Statistics on China’s Pharmaceutical Industry in 2009 • Approval on Drug Registration in 2009 • International Exchanges on Drug Registration in 2009 • Progress on Anti-Counterfeiting Drugs in 2009

  3. Progress on Laws and Regulations concerning Drug Registration

  4. Laws and Regulations on Drug Registration Drug Administration Drug Registration Technical Guidelines on Drug Research

  5. Laws and Regulations on Drug Administration laws Laws and Regulations on drug administration Administrative regulations SFDAdecrees Normative documents Technical Guidelines on Drug Research

  6. Laws and Regulationson Drug Registration

  7. Laws and Regulations on Drug Registration ■Other Normative Documents Guidelines on Protection over TCM Products (2009) Requirements on Biological Products Requirements on File Management of APIs and Excipients (will be implemented in 2010) Provisions on Hospital Preparations (Interim)

  8. Laws and Regulations on Drug Registration Provisions on Drug Standards are being drafted and will be implemented in 2010.

  9. Provisions on Drug Registration15 Chapters and 177 Articles

  10. Four Versions  Provisions on New Drug Approval, implemented on May 1, 1999 Provisions on Drug Registration (interim), implemented on December 1, 2002 Provisions on Drug Registration, implemented on May 1, 2005; Provisions on Drug Registration, implemented on October 1, 2007. Provisions on Drug Registration

  11. Supplementary Documents for the Newly Revised Provisions on Drug Registration • Supplementary Requirements on Registration of TCMs (22 Articles) • Requirements on On-Site Inspection for Drug Registration (6 chapters and 55 articles) • Requirements on Special Review and Approval for Drug Registration (22 Articles) • Requirements on Registration of Technical Transfer of Drugs (4 chapters and 26 articles)

  12.  Improve laws and regulations on drug registration Provide details related to core content of Provisions on Drug Registration Enhance practicability of the Provisions  Combine supervision and service Supplementary Documents for the Newly Revised Provisions on Drug Registration

  13. Requirements on Special Review for Drug Registration

  14. Foundation • Forty-fifth article of Provisions on Drug Registration: specific requirements on special review shall be drafted independently

  15. General Principles and Objectives Early intervention, prioritized review, multi-channel communication, and real-time information updating Strike a balance between promoting innovation and controlling risks Encourage and support the development of new drugs

  16. Major Content 1、Adopt multiple measures to promote innovation 2、Enhance risk control to better regulate

  17. Adopt multiple measures to promote innovation • Independent channel and prioritized review independent filing independent coding prioritized review limited timeframe

  18. Adopt multiple measures to promote innovation • Convenient, scientific and reasonable access mechanism • If consistent with items 1 and 2 of the 45th article, start the procedures when submitting clinical application, and confirm within 5 working days • If consistent with items 3 and 4 of the 45th article, start the procedures when submitting production application, and organize expert review in 20 days • If included in special review when submitting clinical application, include directly in the procedures when submitting production application.

  19. Adopt multiple measures to promote innovation • Timely intervention, and communication mechanism on key stages • Early communication time: before applying for clinical trials content：application for special review, key technical issues • Specialized communication time：during technical review and during clinical trials content ：key security issues，clinical trial plan，evaluation on phased clinical trials

  20. Adopt multiple measures to promote innovation • Timely gather supplementary materials through multiple channels • On review conferences participated by applicants and experts • After meetings proposed by applicants • For key security issues • According to notices on supplementary information • Allow changes in clinical services to improve efficiency • Timeframe increased from 4 months (for common application) to 8 months

  21. Enhance risk control to better regulate • Make risk control plan when submitting application, and allow market entry upon meeting certain conditions. • Set up an exit mechanism for application for new drug registration special review • Establish a database for application for new drug registration special review to facilitate public supervision

  22. Four Guidelines on Implementation1.Guidelines on Materials on Independent Filing of Products Subject to Special Review2. Guidelines on Communication Mechanism for Products Subject to Special Review3. Guidelines on Meeting Minutes for Special Review4. Guidelines on InformationRelease concerning Products Subject to Special Review

  23. Progress of Implementation • Twenty-eight products have entered special review procedures, including 23 chemical drugs and 5 biological products. • Twenty-seven products are for APIs, finished products or biological products that have never been marketed in China or any foreign countries. (Article 2.2) One is for a new drug that has therapeutic advantages or there is no effective treatment for the diseases. (article 2.3) • Other 11 products which are evaluated according to the Requirements on Special Review and Approval are for drugs or vaccines for the treatment and prevention of H1N1.

  24. Requirements on Registration of Technical Transfer of Drugs

  25. To Encourage the Innovation To Ensure the Quality To Promote the Concentration and Saving To Control the Risk To Open the Transfer Market To Regulate the Registration To Save the Cost To Stimulate the Market P0licy Points

  26. Requirements on Registration of Technical Transfer of DrugsKey Point 1 • To Encourage the Innovation to encourage the combination of research and production, to promote the commercialization of research projects, to promote the introduction of foreign new technology and to show the strong commitment on the innovation.

  27. Requirements on Registration of Technical Transfer of DrugsKey Point 2 • To Promote the Concentration and Saving to encourage the good companies to carry out asset restructuring, to rationally allocate the resources, to adjust the product structure, to update the technologic capacity and to make full use of the advantages, so as to promote the concentration of the entire industry.

  28. Requirements on Registration of Technical Transfer of DrugsKey Point 3 • To Open the Transfer Market on the basis of new drug technical transfer, to enlarge the scope of transfer and allow the technical transfer for new drug prior to the expiry of monitoring period as well as the transfer of manufacturing technology after the expiry of monitoring period.

  29. Technical Review Clinical Trial Transferor Transferee BE study Other study Batch production Requirements on Registration of Technical Transfer of DrugsKey Point 4 • To regulate the Registration to regulate the registration process between the two sides of the technical transfer by setting up criteria on the qualification, technical standards and requirements. In the past, there was no need to carry out technical review and clinical validation before the technical transfer of the new drug , now things have been changed and the technical threshold has been improved.

  30. Requirements on Registration of Technical Transfer of DrugsKey Point 5 To control the Risks to control the safety risks by three methods, including dynamic control, static control and procedure control. • Static Control: high risk products are not applicable for technical transfer; • Dynamic Control: Where high risks are newly discovered, the technical transfer shall be ceased. • Procedure Control: where safety risks are discovered during the process of technical review, the technical transfer shall not be approved.

  31. Requirements on Registration of Technical Transfer of DrugsKey Point 6 • To Ensure the Quality with the strict technical review and the validation research carried out by the enterprises, the quality of the products before and after the transfer shall be consistent. Safety, Efficacy, and Quality Control

  32. Requirements on Registration of Technical Transfer of DrugsKey Point 7 • To Save the Cost The companies are able to gain the license by technical transfer, not by changing dosage forms or applying for generic drugs. By these means, the cost on research and development as well as timing could be saved, the low-level redundant production can also be reduced. The one-one transfer may also enable us to control the total number of drug approval licenses.

  33. Requirements on Registration of Technical Transfer of DrugsKey Point 8 • To Stimulate the Market The enterprises can restructure their assets by implementing technical transfer. The market of pharmaceutical technology could be promoted and the merger and cooperation could also be encouraged.

  34. Technical Guidelines on Drug Research

  35. Technical Guidelines on Drug Research  To regulate the drug research activities and to promote the level of drug research;  The introduction of ICH guidelines; To deal with the global drug research and to promote the mutual recognition on drug registration as well as the standard harmonization;  To improve the requirements on drug safety by considering the new problems discovered during the daily regulation.

  36. Technical Guidelines on Drug Research Formally promulgated: 80  chemical drugs: 31 (the Technical Guidelines on Drug Carcinogenicity Study will be issued soon.)  TCMs: 12  Biological Products: 26  General Subjects: 6  General Principles: 5

  37. Technical Guidelines on Drug Research Asking for Comments Chemical Drugs: 4 TCMs: 1

  38. Technical Guidelines on Drug Research Cases： taking the problems detected by regulation into consideration, SFDA issued some technical requirements and guidelines into consideration since 2008 in order to improve the requirements on drug safety.  Basic Technical Requirements on Injections  Basic Technical Requirements on Multi-Compound Bio-Chemical Injections  Technical Guidelines on the Research on Changes of Marketed Chemical Drugs  Technical Guidelines on the Research on Changes of Marketed TCMs.

  39. Major Measures adopted on Drug Registration

  40. To regulate the on-site inspection for drug registration; • To carry out the evaluation on the implementation of GCP; • To initiate the review process on drug re-registration; • To stick to the science-based evaluation and to strengthen the control of risks; • To use all kinds of methods to ensure transparency; • To rationally allocate the resources and to improve the efficiency of technical review.

  41. To regulate on-site inspection for drug registration In order to unify the standards and procedures, the provincial Food and Drug Administrations have developed the following documents for the on-site inspection for drug registration: —implementation guidelines and working procedures —SOPs and other requirements for inspectors In 31 provinces of China, we have carried out 3721 on-site inspections for drug registration, among them, 1133 are for new drug applications, 1198 are for generic drug applications and 1390 are for the application on changes.

  42. To carry out the evaluation on the implementation of GCP • To carry out the re-check on GCP clinical research institutes • To carry out on-site inspection on the clinical trials of imported drugs and to evaluate the implementation of GCP.

  43. To initiate the review process on drug re-registration • Every province has developed a work plan for re-registration; • 3028 products got re-registered throughout China.

  44. To stick to the science-based evaluation and to strengthen the control of risks • To carry out the research on the CTD of generic chemical drugs; • To develop and implement the Technical Guidelines on Drug Carcinogenicity Study; • To adopt the third party validation in order to ensure a reliable and scientific review result; • To hold the specific seminars and consultations in order to solve the common problems during the technical review, to unify the review standards and to ensure the consistency of the review result.

  45. To use all kinds of methods to ensure transparency • To make almost 70 review cases public; • To have communication with the applicants by expert consultation, consultation meeting, video conference, teleconference, etc. • When reviewing the H1N1 vaccines, technical review was organized in a public way. The principles of public votes and public involvement were introduced in order to ensure the safety and efficacy of vaccines as well as the transparent and opened evaluation. • To use different methods such as consultation day, opening day, mailbox of the director general in order to strengthen the communication with the society, to promote the openness and transparency of technical review and to establish a “sunshine” review gradually.

  46. Methods Introduced in 2009 to Ensure the Openness and Transparency of the Technical Review

  47. To Initiate the Special Procedure and to Ensure the Disease Prevention and Control In order to deal with emergencies, SFDA issued the following documents: • Notice on the Preparation of H1N1 Vaccine Production • Work Plan on the Special Review and Approval for H1N1 Vaccines • Work Plan on the Review and Approval of H1N1 Vaccines • Key Items on the Research and Development of H1N1 Vaccines • Notice on Strengthening the Regulation on Research and Development of H1N1 Vaccines • Notice on the On-Site Inspection for the H1N1 Vaccine Samples for Clinical Trials. • Notice on Issuing the Approval License for H1N1 Vaccines

  48. To Initiate the Special Procedure and to Ensure the Disease Prevention and Control • To approve 10 H1N1 vaccines for marketing; • To approve the importation of Zanamavir Powders; • To approve the enlarged production and changed manufacturing process of Phosphate Oseltamivir.

  49. To Promote the IT System on Drug Registration • The NDRC approved SFDA’s proposal on Phase I IT System on Drug Regulation on September 30, 2009. • The Department of Drug Registration established the IT system on the Insert Sheet and Labeling of Drugs and initiated the testing program on that system. IT systems to be established in 2010： • IT system on the Filing of APIs and Excipients. • IT system on the Drug Standards Management

  50. Data Analysis on Statistics of Drug Registration in 2009

More Related