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An Overview: New Drug Registration System and Approval Process in China James S. Yan, PhD, MD, DABT Sr. Director and Site Scientific Lead Covance Pharmaceutical R&D (Shanghai) Co. Ltd. CONFIDENTIAL China Pharma Market 2012 Parma Market: Global – 1 trillion US$ China - ~150 billion US$ • China Pharma Market currently is the third largest market in the world • It is estimated that it will be the 2nd(in 2015) and 1st (2020) largest market 2 CONFIDENTIAL Presentation Outlines • China drug regulation laws and policies • The China Food and Drug Administration (CFDA) – Structure – Main responsibilities • The new drug registration in China – Drug classification – Requirements – Procedures • The latest changes and updates of China regulations for new drug registration • How Covance can help our clients achieve a successful application of their drug registration in China 3 CONFIDENTIAL Poll #1 How familiar are you with the drug registration system and approval process in China? • • • • Not at all familiar Slightly familiar Moderately familiar Very familiar 4 CONFIDENTIAL Drug Laws, Regulations and Policies • Three key drug laws and regulations – Drug Administration Law of the People’s Republic of China (Dec. 01, 2001) – Regulations for Implementation of Drug Administration Law of the People’s Republic of China (Sept. 15, 2002) – Regulations on Administrative Protection for Pharmaceuticals (Jan. 31, 1993) • Drug regulation policies – Provisions for Drug Registration (July 10, 2007) – Special Review and Approval Procedure for Drug Registration (Nov. 18, 2005), revised in 2009 5 CONFIDENTIAL China Food and Drug Administration (CFDA) The State Food and Drug Administration (SFDA) 2003 - 2013 The China Food and Drug Administration (CFDA) 2013 – 6 CONFIDENTIAL China Food and Drug Administration (CFDA) Seven Major Affiliates of CFDA 7 CONFIDENTIAL China Food and Drug Administration (CFDA) • Main responsibilities – The implementation and enforcement of pharmaceutical rules and laws – Regulations for all drug, food, supplement, medical device, and cosmetics in China – The inspection, sales, research, and advertisement of drug, food, supplement, medical device, and cosmetics products – Drug approvals 8 CONFIDENTIAL The New Drug Registration Process • Drug Classification in China – Chemical Drugs (small molecules): • Total 6 Classes • 2 classes are related to NCE – Class 1: NCEs that have not been marketed in the world, – Class 3: NCEs which marketed in outside China – Biological Products: • Total 15 Classes and all are considered as new drug – Class 1: New biologics – Class 2: Monoclonal Antibody – Class 3: Gene therapy and cell therapy – Traditional Chinese Medicines (TCM) • Total 9 classes 9 CONFIDENTIAL The New Drug Registration Process • The Types of Drug Application/Registration in China – New drug • Classes 1 and 3 chemical drugs • All biologics – – – – 10 Import drug: NCE and Biologics Generic drug: Other 4 classes of chemical drugs Dietary supplements Drug re-registration CONFIDENTIAL The New Drug Registration Process • The Requirements for New Drug Registration (including Import Drug Registration) – – – – 11 Overview Summary Pharmaceutical Sciences (CMC) Non-clinical Pharmacological and Toxicological Research Clinical Research CONFIDENTIAL The New Drug Registration Process • Two Application Steps – Clinical Trial Application (CTA or IND) – Marketing Application (NDA) • Two Review Stages – Provincial FDA Review: • Dossier Content/Format Checking • On-site Inspection – China FDA (CFDA) Review • Technical review by the Center for Drug Evaluation (CDE) • Approval by CFDA 12 CONFIDENTIAL The New Drug Registration Process • CTA (IND) Approval Process for New Drugs From CFDA Website: http://eng.sfda.gov.cn/WS03/CL0769/61659.html 13 CONFIDENTIAL The New Drug Registration Process • CTA (IND) Approval Process for Import Drugs From CFDA Website: http://eng.sfda.gov.cn/WS03/CL0769/61658.html 14 CONFIDENTIAL The New Drug Registration Process • Marketing Application (NDA) Approval Process (for import drug) From CFDA Website: http://eng.sfda.gov.cn/WS03/CL0769/61657.html 15 CONFIDENTIAL The Latest Changes and Updates Special Review and Approval for New Drug Registration (2009) • Active ingredients extracted from plants and animal or mineral resources and their formulations that have never been marketed in China. • Active pharmaceutical ingredients (APIs) and their formulations or biological products that have not yet been approved for domestic and foreign markets. • New drugs showing clear therapeutic advantages in the treatment of AIDS, malignant tumors, and rare or orphan diseases. • New drugs that may be used to potentially treat diseases for which no known effective therapy is yet available. 16 CONFIDENTIAL The Latest Changes and Updates Special Review and Approval for New Drug Registration (2009) • The new regulation is intended to – Encourage drug innovation in China – Develop the principles of ’early involvement, priority evaluation, multiple channel communication, and dynamic submission of supplemental information’. – Stipulate relevant provisions on the conditions, procedures, and requirements of the special approval process for new drugs – Specify rights and obligations of applicants in the special approval process 17 CONFIDENTIAL The Average of the Review Time From China Drug Review 2012 Annual Report, Feb 28, 2013 CFDA 18 CONFIDENTIAL The Review Timelines of CTA in Major TAs From China Drug Review 2012 Annual Report, Feb 28, 2013 CFDA 19 CONFIDENTIAL Registration Application from 2009 – 2012 Number of various registration applications • The number of Category 1.1 (New Drug) applications was around 70 • Very small portion compared with other Categories From China Drug Review 2012 Annual Report, Feb 28, 2013 CFDA 20 CONFIDENTIAL The Latest Changes and Updates Major Reforms to Drug Regulatory Process (2013) SFDA proposed the fast-track drug registration processes for China-based innovation and clinical priorities and to promote the healthy development of China’s pharmaceutical industry. 21 CONFIDENTIAL The Latest Changes and Updates Major Reforms to Drug Regulatory Process (2013) • Innovative drugs: – Create a favorable environment for the R&D of innovative new drugs – Accelerate technical reviews and regulatory approvals • Generics: – – – – – 22 Revised national strategy for generic drugs High clinical priority generics will receive fast-track reviews Discourage the generic drugs which offer little clinical value Require the clinical bioequivalence testing for all generic drugs Generate the Chinese version of the United States' Orange Book CONFIDENTIAL The Latest Changes and Updates Major Reforms to Drug Regulatory Process (2013) • Clinical trials: – Strengthen the quality and management of pharmaceutical clinical trials – Independent ethics committee to evaluate the clinical trials – Clinical trial transparency • Pediatric drugs: – Encourage the development of pediatric drugs through suitable tendering and pricing and reimbursement (P&R) incentives – Prioritize the suitable generic drugs for pediatric use with the potential for exclusivity periods. 23 CONFIDENTIAL Covance Laboratory • One of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. • Services include: – – – – – Discovery and translational services Early development services Clinical development services Central laboratory services Commercialization services • Mission: To help our clients bring the miracles of medicine to market sooner 24 CONFIDENTIAL Covance China Clinical Dev. Services Office • Clinical Operations Home base • CDARO (clinical data analysis and reporting) • Medical Affairs • Drug Safety Beijing • Regulatory Tianjin • QC/QA Xi’an Shiyan Wuhan Chengdu R&D laboratories Changsha • Central Laboratory Services (including biomarkers and genomics) Guangzhou • Non-clinical Safety Assessment • DMPK Services (In Vivo & In Vitro) • Bioanalytical Services (Small and large molecules) • DTS (in vivo Pharmacology, PK/PD) 25 CONFIDENTIAL Covance China: Early Development • State of Art facilities with 90,000 square feet • Consistency with Covance global standard – Global operation procedures and training programs – Common technology platforms and flexible scientific and technical resources • Accreditation/Regulatory Compliance – – – – – 26 Certificate of Chinese Quality and Animal Bureau Full accreditation of AAALAC Certificate of Belgium GLP with OECD GLP Principles Certificate of China FDA (CFDA) Compliance with US FDA GLP Practice Regulations (21CFR Part 58) CONFIDENTIAL Covance China: Early Development Drug Discovery Preclinical Development Drug Discovery In-Vivo Pharmacology* Nonclinical Safety Assessment Lead Optimization* Additional Services* PK Screening* DMPK In-Vitro and In Vivo Study* Non-GLP and GLP compliant studies* Provide all services in preclinical development to support clinical studies 27 CONFIDENTIAL Covance China: Regulatory Services • Regulatory Support of New Chemical Entities – Global Regulatory Strategies – Regulatory Support of All Phases of Clinical Development (IND/CTA, import permits, export waivers, GCP auditing, etc.) – CMC (Chemistry, Manufacturing, Control) – Medical Writing – Labeling – Translations of Technical Documents – Coordination of Regulatory Certificates – Medical and Clinical Consulting • Consulting on the Complete Product Development Program (all phases) – Reviewing and Assessing Clinical Protocols – Reviewing Safety and Efficacy Related Issues During Product Development – Adjudicating Clinical Data 28 CONFIDENTIAL Summary • Chinese pharmaceutical industry has experienced significant growth and will continue grow with over 20 percent annually • In next several years, China pharmaceutical market will become the 2nd or largest in the world. Most of the pharmaceutical companies have been expanding their footprint in efforts to enter the Chinese drug market • Drug registration and regulation in China is a complicated and timeconsuming process, involving a number of regulatory bodies at various levels of central and local governments • It is very critical for pharmaceutical companies to understand the drug registration system in China and to know how to get the drug approved with China pharmaceutical regulatory authority • Covance, as the world largest and most comprehensive drug development services company, can help to achieve the successful application and drug registration in China 29 CONFIDENTIAL Q and A Thank you very much! Contact information: Name: James Yan Email: [email protected] CONFIDENTIAL