FDA FDA Updates Updates and Developments and Developments Maria Lourdes C. Santiago, MSc, MM Officer-in-Charge Center for Drug Regulation and Research PAPPI’s 1 st GMM 2013 26 July 2013 1
Presentation Outline Presentation Outline Regulatory Framework Our Vision, Mission, Quality Policy CDRR Organizational Structure CDRR Strategies Regulatory Updates Accomplishments Commitments for the 2 nd sem 2013 Way Forward 2
Regulatory framework 3
Elements of regulatory framework to Elements of regulatory framework to assure quality and safety of drugs assure quality and safety of drugs Licensing/ Accreditation of establishments • – GMP, GDP, GSP, GCP and GLP Pre-marketing assessment • – of quality, safety and efficacy (for innovative medicines) and – quality + interchangeability (for generics) Post-marketing surveillance • – SAFETY: • Medicine safety monitoring (monitoring balance of benefits/risk of harm) – QUALITY • Quality testing of samples • Continuous monitoring of compliance with GMP, GDP, GSP, etc. 4
Requirements for MA • Valid license to operate (LTO) as proof of compliance to GMP, GDP and GSP • Submission of registration dossier as described in the national guidelines and/or ASEAN Common Technical Documents (ACTD))/ICH CTD – Analytical Validation – ASEAN Stability Guidelines – Process Validation – Bioequivalence – ASEAN Variation Guidelines – ICH Safety and Efficacy Guidelines • Representative Samples/Labeling materials – product information 5
PMS ACTIVITIES – Pharmacovigilance Safety monitoring of drugs on the market for unexpected health risks and informing the public of risks posed by specific drugs and other health products; – Monitoring, collecting, sampling and testing of drugs – Audits and inspection of manufacturers/ distributors/ retail outlets – Consumer reporting of ADR – Product recall / Administrative sanctions 6
Vision, Mission & Quality Policy 7
Our Vision, Mission and Quality Policy MISSION VISION To ensure the safety, efficacy, purity and quality of products we regulate To be an internationally recognized center of through effective implementation of the regulatory excellence safeguarding the health of the Filipinos national regulatory framework consistent with international best practice Quality Policy Our highest commitment is to ensure the safety, efficacy and quality of health products. Toward this end,: we commit to establish science based standards as basis for regulatory policies, to continually improve and maintain our competence to deliver quality public service with integrity 8
CDRR Organizational Structure 9
CENTER FOR DRUG REGULATION AND RESEARCH OFFICE OF THE CENTER OIC LICENSING AND PRODUCT RESEARCH AND REGISTRATION STANDARDS DEVELOPMENT DIVISION DIVISION STANDARD CLINICAL PMS DEVELOPMENT RESEARCH Section Section Section Manufactur Distributors/ Vaccine and Clinical Pharma/ Veterinary ers Retail Outlets Biologicals Drug Trial Human Drug Traders Licensing Registration Evaluation Licensing Registration Registration 10
Licensing and Registration Division • Licensing (Initial Issuance /Amendments) • In coordination with RFO • Oversight function over Regional inspectors including inspection of the establishments • Evaluation and registration of human and veterinary drugs • Clinical and CMC • Post approval changes • Establishment and product verification and certification • Issuance of CPP and other clearances 11
Product Research and Standard Development Division • Conduct of research and development of standards • Development of strategies for PMS (Identify all PMS activities) • Compliance monitoring ( Analysis of field data) • Accreditation of CROs and other facilities engaged in the conduct of clinical research • GCP, GLP, GTP • Oversight of clinical research 12
Other functions of the Center Other functions of the Center • Standards development including policies and guidelines ( PPO) • Provision of technical assistance in capacity building of stakeholders (PPO) • Attendance to ASEAN Harmonization or international meetings (PPO) • Quality Assurance - Development and maintenance of Quality Management System (PPO) 13
CDRR MANPOWER COMPLEMENT CDRR MANPOWER COMPLEMENT during transition during transition Total no. of Permanent Contractual CDRR personnel T- 27 T- 27 74 NT- 16 NT- 4 14
List OF CDRR Officers List OF CDRR Officers Center OIC – Maria Lourdes C. Santiago LRD OIC – Melody Zamudio Licensing Supervisor - Evangeline Manalo Registration /Post Approval Changes Biotech derived: Grace Medina Veterinary: Edgar Calbitaza New Drug/Generics: Wenzel Asprec PAC/Amendments: Lisa Pajarillo CTU: Tito King PV: Lanette Querubin PRSDD OIC - Regina Obligacion 15
CDRR Strategies 16
CDRR Strategic Objectives Significant changes have been introduced which aims to: • provide earlier/timely access to quality medicines, • reduce regulatory burden by streamlining some work processes • increase time savings and • enable greater operational efficiency WITHOUT COMPROMISING SAFETY, EFFICACY AND QUALITY STANDARDS 17
CDRR Strategies 1. Work on improving the efficiency, clarity and transparency of the CDRR work process – Introduce and implement the Good Regulatory Practice and Good Management Review Practice 3. Review and update the existing policies and regulations to align with the international standards 4. Draft new polices to keep abreast with the new and emerging technology in the field of drug development 18
CDRR Strategies 5. Advocate a robust yet flexible and risk based regulatory system that places an utmost priority on patient safety while enabling timely access to potentially new life- saving drugs and other quality generic drug products. 6. Enhance both the premarket and post market regulatory process in coordination with the FROO. Priority is given to drug products of higher risks (phased approach). 7. Develop a coordinated approach with the different FROOs and other government agencies on safety and quality issues with an immediate impact on patient safety through PMS and PV. 19
CDRR Strategies 8. Continuous re-training and re-tooling of all technical and administrative personnel to ensure consistency in the interpretation and implementation of the guidances 9. Establish closer collaboration with other DRAs to broaden our knowledge and strengthen the regulatory capabilities as we aim to be internationally recognized. 10. Regular communication/ dialogue with industry stakeholders to ensure transparency and smoother transition through quarterly “KAPIHAN AT TALAKAYAN SA FDA” 20
Regulatory Regulatory Updates: Updates: DOH/FDA DOH/FDA Issuances Issuances 21
New Authorization Process 29 July 2013 22
Republic of the Philippines Department of Health Food and Drug Administration FDA Issuances FDA Memorandum Circular No. 2013- • 001 , Guidelines on the Submission of LTO and CPR Application with Electronic Copy (e-copy) FDA Memorandum Circular No. 2013- • 001-A, Amending FDA Memorandum Circular No. 2013-001 29 July 2013 23
Republic of the Philippines Department of Health Food and Drug Administration FDA Issuances • FDA Circular No. 2013-008 ADOPTION OF THE ASSOCIATION OF THE SOUTHEAST ASIAN NATIONS (ASEAN) POST-MARKETING ALERT SYSTEM (PMAS) FOR DEFECTIVE OR UNSAFE PROCESSED FOOD PRODUCTS, PHARMACEUTICAL PRODUCTS, TRADITIONAL MEDICINES AND HEALTH SUPPLEMENTS, AND COSMETIC AND HOUSEHOLD HAZARDOUS PRODUCTS AND DEVICES This Circular provides for the adoption of PMAS as a national guideline for the surveillance of unsafe and defective processed food products, pharmaceutical products, traditional medicines and health supplements, cosmetics, and devices. 29 July 2013 24
Republic of the Philippines Department of Health Food and Drug Administration FDA Issuances FDA Circular No. 2013-004 • POST MARKETING SURVEILLANCE (PMS) OF AUTHORIZED DRUG PRODUCTS This Circular sets the standards and requirements on PMS system that defines the duties, responsibilities, and obligations of the Market Authorization Holder (MAH) and the Qualified Persons in Regulatory Affairs (QPIRA) in order to maintain the availability and accessibility of their products in the market. 29 July 2013 25
Republic of the Philippines Department of Health Food and Drug Administration FDA Issuances • FDA Memorandum Circular No. 2013-004 QUALIFIED PERSON IN INDUSTRY (FOOD, DRUG, COSMETIC, AND DEVICE) REGULATORY AFFAIRS (QPIRA) TRAINING-ACCREDITATION GUIDELINES This Memorandum Circular details the guidelines for the training and accreditation of liaison officers and regulatory affairs officers to ensure that the QPIRAs demonstrate competence and professionalism in preparing and submitting the correct and complete applications and dossiers. 29 July 2013 26
Republic of the Philippines Department of Health Food and Drug Administration FDA ISSUANCES CDRR Memorandum No. 0004, s. • 2013 [ Follow-ups, Technical Inquiries and Face-to-Face Interactions] FDA Memorandum Circular No. 2013- • 04 [ Follow-up of Applications FDA Memorandum Circular No. • 2013-019 [Decking Schedule of Drug Product Registration Applications ] 29 July 2013 27
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