(Historic Developments Undertaken by CFDA)

Transcription

1 Review Impact of Emerging CFDA (China FDA) Guidelines/Standards (Historic Developments Undertaken by CFDA) Qiang Zheng Peking University, Beijing China IPAC-RS/RDD 2016 Symposium Scottsdale

2 Timeline of Major CFDA Policy Initiatives Date CFDA Announcement Reform of the user fee program Chinese Pharmacopoeia 2015 (particle size distribution, dose uniformity) Crackdown on data integrity Reform of the drug and device approval programs (State Council) Reform of the drug application classification Reduced requirement for BE studies Pilot of the marketing authorization holder program CTD requirement for drug registration Generic drug quality consistency evaluation program (State Council) Suspension of the electronic tracking program Requirement for importing reference listed drugs Inspection of MDI manufacturers for CFCs reduction Guideline of BE waivers (draft) The current CFDA leadership took office in January 2015

3 The New User Fee Program (In US$1,000) Domestic Import NDA ANDA Supplement IND Manufacturing/Approval Without IND With IND Format Review 2 2 Science Review Re-registration (every 5yrs) Provincial FDAs 4 In comparison, the previous NDA fee was US$5,000 In perspective, fees are several folds over the current operating budget

4 Crackdown on Data Integrity Violation On July 22, 2015, CFDA announced that all applicants shall self audit clinical trial data integrity, and report the results by August 25, The applicants can withdraw applications before the deadline, or face CFDA inspection and regulatory action if found guilty, including: an applicant will be forbidden to submit new applications for three years, a clinical trial organization may lose its license for conducting trials, all guilty parties, including CROs, will be black listed. ~90% of the clinical trial organizations (hospitals) has closed their clinical trial operation, and >10-fold rate hike for conducting clinical trials by end of 2015

5 Clearing Backlog Out of 1,622 pending finished clinical trial applications on July 22, 2015, 951 (59%) were withdrawn by December 31, The unofficial numbers are much higher: 89% domestic applications withdrawn 20% MNC applications withdrawn (PhIRDA 2016) Expenses for conducting a bioequivalence (BE) study: 70% of the domestic applications paid less than US$50,000 70% of the MNC applications paid more than US$150,000

6 Reform of the Drug & Device Review/Approval Programs (The State Council February, 2016) Goals: improve program quality by emphasizing science and efficiency aim for international program quality and efficiency standard Tasks: clear application backlogs by 2016 meet review/approval timeline by 2018 improve generic drug quality (RLD vs. CMC specs) prioritize based on clinical needs (MCCT, 505 b1-b2-j ) pilot the marketing authorization holder program (free up market) increase programs transparency Support: the new user fee program

7 The Generic Drug Quality Consistency Evaluation Program (State Council August 8, 2015) Goals: conform to international standards of generic drugs filter out low quality products (and manufacturers too) Tasks: finish, by 2018, all products in the Essential Drug List ( ~ 270) campaign-style triage review of over 100,000 approved generics Support: evaluation performed by CFDA s analytics unit: National Institutes of Food and Drug Control (NIFDC), not Center for Drug Evaluation suspension of new generic drug applications (since )

8 Reform of the Drug & Device Review/Approval Programs (Challenges) Goals: (qualified reviewers, (2017) 5000 (2025)) aim for international program quality/efficiency standard (fee or tax?) Tasks: clear backlogs by 2016 (RLD import, BE facilities) meet review/approval timeline by 2018 (local procurement) improve generic drug quality (R&D, manufacturing, equipment) prioritize based on clinical needs (definition of new, pricing) pilot the marketing authorization holder program (liability) increase program transparency (legitimate protection) Support: the new user fee program (collection vs. usage of fees)

9 Why Making Historic Changes Now? Crisis: the ecosystem for industry is deteriorating: lack of true innovation lack of incentives to safeguard product quality integrity losing to survival instincts or pressure of greed forever long waiting time for approval (6-10 years) growing overcapacity ( low risk of supply shortage) growing public awareness and demand for quality Resolve: attack the eco crisis before it becomes a safety crisis

10 Thoughts behind the Historic Changes Not to re-invent the wheel: product, science, technology regulation, guidance, policy concept, framework theory, experience A drug with proven efficacy, safety and quality worldwide is likely so in China

11 Current Developments Adopt international standards and practices: thousands of FDA guidances being translated into Chinese hiring of reviewers of all disciplines (volunteers? referrals?) ectd FDA WLs/ULs/483s studied for establishing compliance templates data integrity guidance (1 st draft due this month) data integrity on GMP, and product R&D increasing overseas inspections

12 Speculations (Wishes) Relax the certificate requirements for clinical study facilities Accept overseas BE data Simultaneous application for simultaneous approval Increase rationality of policy development/implementation** Streamline the organization structure and function of CFDA units: Center for Drug Evaluation (review, +120 FTEs) National Institutes for Food and Drug Control (analytics, FTEs)** Center for Food and Drug Inspection (compliance, +40 FTEs) Chinese Pharmacopoeia (standards, +40 FTEs)

13 Summary Leaders have spoken Initiatives are out But the old system remains in place Risks Opportunities integrity focus science-based risk-based harmonized predictability long backlogs inconsistency? requirements? fairness? IP protection

14 THANK YOU