Pharmaceutical Regulatory in Indonesia. Togi J. Hutadjulu Director of Drug and Biological Product Evaluation

Transcription

1 Pharmaceutical Regulatory in Indonesia Togi J. Hutadjulu Director of Drug and Biological Product Evaluation New Delhi, 17 November 2017

2 THE REPUBLIC OF INDONESIA OUTLINE Indonesian Profile BPOM Profile Regulatory oversight of Pharmaceutical and Biological Profile of Indonesian Pharmaceutical Facilitation of Pharma Developmetn The way Forward

3 INDONESIA PROFILE Republic of Indonesia Archipelago of islands, lies across the equator Area: land km 2 (37% of total); ocean km 2 (63% of total) 34 provinces, 514 regencies/ municipalities Tropical country, two seasons (dry and rainy) The world s 4 th most populous country: 260,5 Million, nearly 60% is below 30 years of age More than 370 ethnics, more than twice as many distinct languages as well as languages diversity

4 GDP & Health Expenditures, GDP Indonesia: Gross domestic product (GDP) per capita from 2012 to 2022 (in U.S. dollars) Year % of Health Expenditure to National Budget ** Total Health Budget** % Rp 52 Trillion % Rp 67 Trillion % Rp 71 Trillion % Rp 104 Trillion % Rp 104 Trillion (USD 8 Billion) *World Bank **Ministry of Finance Indonesia (

5 BPOM PROFILE

6 Badan POM BPOM is a non-ministerial government institution which directly responsible to The President of Republic of Indonesia. In performing its duties, BPOM coordinate with Ministry of Health (under Presidential Decree No. 103/ 2001). BPOM has 33 provincial offices with supported by accredited laboratories in each office (ISO/IEC 17025: 2005) The total number of employee is 4000 staffs

7 COMMODITIES UNDER BPOM CONTROL Pharmaceutical Foods Biologicals Traditional Medicines Health Supplement Cosmetics Hazardous Substances

8 NRA Recognition through WHO-NRA Assessment 1. Open opportunity for Indonesia to export vaccine produced by Indonesia s vaccine manufacturer into international market 2. Support immunization program with Quality assured vaccines & support MDG 4 & 5 achievement. 6. Regulatory oversight of clinical trial 5. Regulatory Inspections Scope of WHO-NRA Assessment (for producing country) 1. Marketing Authorization & Licensing Activities Regulatory System 4. Laborator y Access 2. Pharmacovi gilance activities incl. Surveillance of AEFI 3. NRA Lot Release

9 Applied in 2008, assessed in 2010 and 2011, and finally NADFC became the 41st member of PIC/S on 1 July 2012, organization for collaboration of GMP inspectorates in the world collaboration. Chances

10 3(Three) PILLAR SYSTEM WITHIN THE MANDATE OF THE NADFC (BADAN POM) INDONESIA Scientific Review and Good Regulatory Practices Protection of Public Health Safety Measure and Law Enforcement Supporting R&D and Product Innovation

11 Regulatory Oversight for Pharmaceutical

12 Development stage Approval Stage Production Stage Distribution Stage Administration To protect the rights and safety of the clinical trial subjects Clinical trial protocol evaluation, approval n conducting audit are appropriate with CGP Preclinic and Clinical data Evaluation to support safety and efficacy Quality data Evaluation GMP certification Inspection / audit GMP Compliance GDP compliance Inspection Investigation of validity Monitoring of Quality Monitoring of Adverse Drug Reactions / Pharmacovigilance

13 Drug Control System, Including Vaccines & Biological Products Pre Market Control GMP implementation control on pharmaceutical industries Post Market Control Inspection on drug manufacturing, distribution and service facilities for monitoring GMP and GDP compliance Clinical Trial Authorization and GCP Inspections Drug evaluation on safety, efficacy, and quality for Marketing Authorization Sampling and testing, including lot release for vaccines Drug labelling and advertisement control Pharmacovigillance system

14 Regulatory Framework On Ensuring Quality, Safety, and Efficacy of Medicine I. PRE SUBMISSION II. MA APPLICATION & PRODUCTION PRE-IND AND IND STEPS or FORMULATION R & D GMP Manufacturers Dossier submission GMP PRODUCTION PRE-MARKET EVALUATION - Manufacturing process development - Clinical development Phase 1 - Safety - Efficacy/ Immuno genicity Phase 2 - Efficacy/ Immuno genicity - Safety - Dose ranging Phase 3 - Efficacy/i mmunog enicity - Safety - Monitoring safety, quality - Inspection - Phase 4 study III. POST-MARKET CONTROL GMP Lab Testing Lot Release AEFI REGULATORY CONSULTATION Control & Enforcement 14

15 Criteria On Drug Evaluation (Risk Based Assessment) Based on Quality data: Active substance Finished product Comply with cgmp QUALITY Based on: Nonclinical studies Clinical studies EFFICACY & SAFETY Evaluation Criteria Product Information Should be: complete Objective Clear To ensure rational medicine use

16 Profile of Indonesia Pharmaceuticals

17 Overview: Pharmaceutical Market in Indonesia Trillion Rupiahs Trillion Rupiahs Indonesia s Pharmaceutical Market Projection 2025 Top 23 in the world 27% of ASEAN pharmaceutical market is dominated by Optimistic Annual Growth: 20% GDP Contribution: % Global Top 15 Indonesia 73% of market is dominated by local Value of Indonesia s Pharmaceutical Market companies Rp 62T Indonesia s Pharmaceutical Export Potential Pharmaceutical Industries 4 government-owned 182 local private 24 multinationals 95% raw materials are imported (value of Rp 21T in 2013)

18 Medicines Produced in Indonesia Generics Products Total 11,910 generic products from 207 manufacturers. Examples of products: Analgesics, antibiotics, antihypertension, anti diabetics, oncologies, OTC, anticoagulant, hormones, etc. WHO Prequalification: Amoxycillin tablet dispersable & Oxytocin injection

19 Biological Products Produced in Indonesia 1.Vaccines Tetanus Toxoid Vaccine Diphtheria Toxoid vaccine Diphtheria Tetanus vaccine Adsorbed Diphtheria Tetanus Vaccine Diphtheria Tetanus Whole cell Pertussis (DTwP) Vaccine Diphtheria Tetanus Whole cell Pertussis-Hepatitis B (DTwP-Hb) Vaccine Diphtheria Tetanus Whole cell Pertussis-Hepatitis B (DTwP-Hb-Hib) Vaccine Hepatitis B Vaccine Measles Vaccine mopv1 Vaccine bopv1,3 Vaccine topv Vaccine (Not produced anymore) BCG Vaccine Seasonal influenza Vaccine 2. Biosimilars Erythropoeitin Alfa Recombinant Glargine Insuline WHO Prequalif ied Vaccine (PQ)

20 Facilitation Development of Pharma Industry

21 Current Situations Global Situations Increasing of integrated economic and population growth impact to the increase of public access to the quality, safe and effective of essential medicines, diagnostics and medical devices. The 67th WHA Resolutions: : Strengthening National Regulatory System in conducting its functions to promote access to affordable, safe and efficacious essential medicines and biologics with assured quality the global health goal to increase public access to affordable, safe and efficacious essential medicines and biological with assured quality. National Situations Implementation of the National Health Insurance becomes another challenges in provision of quality, safety and efficacy medicines, biological products, diagnostics and medical devices. Many of emergence of new diseases that have no treatment available Increase medication needs Increase the need to the life science innovation on Medicines, Biological Products, diagnostics and medical devices.

22 Presidential Instructions No Facilitating on Development of Pharmaceutical and Medical Device Industries. Instruction to Badan POM: to facilitate drug development to support public access and availability of medicines, to support investment in the area of pharmaceutical through facilitating licensing and marketing authorization process, and to encourage industries to increase compliance on regulation and standard.

23 Current Regulation on Product Development Indonesia s Master Plan Presidential Instruction No.6 /2016 Development of pharmaceutical industries as prioritized pharmaceutical industries to become reliable industries. Development of APIs, vaccines, Biotechnology products and natural/herbal products.

24 NADFC SUPPORTS FOR PHARMACEUTICAL DEVELOPMENT IN INDONESIA Facilitation in drug development through IND Mechanism Fast tract registration process (100 Working Days) Facilitation of manufacturing facility development Process Simplification of layout requirement Regulatory assistance

25 Potential of Cooperation Investment by Indian manufacturer on API (starting from chemicals or intermediate) manufacturing (allowed for 100% shares), or in cooperation with Indonesian manufacturer on finished finished product manufacturing, including biological product (upstream and downstream) and small molecule advanced product Technology transfer of manufacturing and product deveopment by establishment of research/ testing labs to support development of product, eg non-clinical trial, formulation and quality control.

26 Potential API Development in Indonesia Statin (Simvast, Atorv., Rosuv) Pantoprazol Clopidogrel ARV (Tenovofir, Entecavir) Betalactam (amoxy) Paracetamol Rifampicin Ascorbic acid Cefalosporin Vitamin B5 Vitamin E (Folic Acid) Beta Caroten Biotin ARV (Entecavir, Tenovofir) Metformin Amlodipin Glimepiride Lanzoprazole Hidrotalcite Retinol

27 Potential Biological Products Development in Indonesia Vaccines IPV Pneumococcal Rotavirus Typhoid conjugate Biotherapeutic Products Trastuzumab Infliximab Rituximab Bevacizumab Blood Products Albumin IgG Blood coagulation factors

28 BPOM POLICIES IN TRADITIONAL MEDICINE DEVELOPMENT 1 REVISION IN TRADITIONAL MEDICINE REGULATION IN ACCORDANCE WITH SAINS AND TECHNOLOGY DEVELOPMENT 1. Revision in Herbal Medicine Category. 2. Revision in Criteria and Procedure for Herbal Medicine Registration 3 GUIDELINES DEVELOPMENT 1. TM GMP Guideelines 2. Guidelines in empirical data for TM (start in 2017) 2 PRODUCT ORIENTED RESEARCH Research Institutions should be equipped with a production site and utilities with TM GMP certification Collaboration enhancement with : a. Traditional Medicine industries with GMP certification b. Industries who have applied GMP in their production site : Raw material (CoA) Process (Validation) Utilities (Qualitification) CONSISTENT Personel (Competent) Quality Assurance 4 COMPETENCY ENHANCEMENT AND REGULATION UNDERSTANDING IMPROVEMENT FOR STAKEHOLDERS BPOM has organized technical training in Good Clinical Practice for stakeholders such as researchers, industry, medical personnel, and Research Organization. BPOM also held a Coaching Clinic Full Spectrum for TM industry personel for understanding improvement in technical requirements of traditional medicine submitted to the registration.

29 The way forward Continuous improvement for increasing access of safe, efficacious, quality medicines to public and for better service delivery to the stakeholders by: facilitating drug approval and GMP certification process Increase number and competency of evaluators and inspctors E-regulatory for drug application and premises sertification aimed for transparency, predictabillity, accuracy and expedited process Improve communication with stakeholders Better implementation of QMS Facilitatation local pharmaceuticals and biologicals development and investment - Facilitation through regulatory consultancy and technical assistance for drug development and investment - Fastrack registration process - Deregulation and process simplification

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