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FDAFDA Updates Updates and Developmentsand Developments

Maria Lourdes C. Santiago, MSc, MM Officer-in-Charge

Center for Drug Regulation and Research PAPPI’s 1st GMM 2013

26 July 2013

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Presentation OutlinePresentation Outline

Regulatory Framework

Our Vision, Mission, Quality Policy

CDRR Organizational Structure

CDRR Strategies

Regulatory Updates

Accomplishments

Commitments for the 2nd sem 2013

Way Forward

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Regulatory framework

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.

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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

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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

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Vision, Mission & Quality Policy

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Our Vision, Mission and Quality Policy

VISION

To be an internationally recognized center of regulatory excellence safeguarding the

health of the Filipinos

MISSION

To ensure the safety, efficacy, purity

and quality of products we regulate

through effective implementation of the

national regulatory framework

consistent with international best

practice

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

Quality Policy

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CDRR Organizational

Structure

OFFICE OF THE CENTER OIC

LICENSING AND REGISTRATION

DIVISION

PRODUCT RESEARCH AND STANDARDS

DEVELOPMENT DIVISION

Manufacturers

Traders Licensing

Distributors/ Retail Outlets

Licensing

Pharma/ Human Drug Registration

STANDARD DEVELOPMENT

Section

PMS Section

CLINICAL RESEARCH

Section

CENTER FOR DRUG REGULATION AND RESEARCH

Veterinary Drug

Registration

Vaccine and Biologicals

Registration

Clinical Trial

Evaluation

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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

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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

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Other functions of the CenterOther 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)

CDRR MANPOWER COMPLEMENTCDRR MANPOWER COMPLEMENT during transitionduring transition

Total no. of

CDRR

personnel

Permanent Contractual

74

T- 27

NT- 16

T- 27

NT- 4

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List OF CDRR OfficersList 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

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CDRR Strategies

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

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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

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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.

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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”

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Regulatory Regulatory Updates: Updates:

DOH/FDA DOH/FDA Issuances Issuances

New Authorization Process

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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

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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.

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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.

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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.

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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 ]

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CDRR Memorandum No. 003, s. 2013 Facilitation of Applications for Product Registration

1. Products to be manufactured exclusively for export ;

2. New drug products considered to be a major therapeutic advance ;

3. The first 5 products of a newly licensed establishment;

4. Products for government programs and projects ;

5. Imported prequalified vaccines

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FDA ISSUANCES

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• CDRR Memo Circular No. 0004, s. 2013

Follow-ups, Technical Inquiries and Face-to-Face

Interactions

• FDA Circular No. 2013-012 Validity of Generic

Labeling Exemption for Pharmaceutical Products

• FDA Memo Circular No. 2013-019 Decking

Schedule of Drug Product Registration

Applications

FDA ISSUANCE

FDA Circular No. 2013-0014

- List of Products Requiring Bioavailability/ Bioequivalence (BA/BE) Studies as Part of the Application for Marketing Authorization in Addition to Rifampicin and the 11 Products Listed in Bureau Circular No. 2006-008

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FDA ISSUANCE

FDA Circular No. 2013-0014

- Expansion of the requirement of BE Studies to cover:

• BCS Class 4 drugs (low solubility, low permeability)

• BCS Class 2 drugs (low solubility, high permeability) not eligible for biowaiver

• Modified-release products for oral administration designed to act systemically

• Subsequent generic products after the patent of the innovator has expired (unless biowaiver can be supported)

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FDA ISSUANCE

FDA Circular No. 2013-0014

- Certain drug products may avail of biowaiver based on the aqueous solubility and intestinal permeability of the API, and dissolution performance of the dosage form:

• BCS Class 1 drugs (high solubility, high permeability)

• BCS Class 2 drugs (low solubility, high permeability) with weak acidic properties

• BCS Class 3 drugs (high solubility, low permeability)

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DOH ISSUANCE

Administrative Order No. 2012-024

- Amendment of A.O. No. 50 s. 2001 Covering Fees and Charges for Accreditation of Bioequivalence Testing Centers and Private Testing Laboratories, as well as, Audits and Inspections

• Bioequivalence testing center accreditation – PHP 20,000 per year [from PHP 10,000 per year]

• GCP/GLP audit of bioequivalence testing center – PHP 15,000 + transportation cost (with per diem of each inspector if facility is outside Metro Manila) [from PHP 5,000]

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FDA ISSUANCES • FDA MEMO CIRCULAR NO. 2013-023

Conversion to Electronic Copy of All Registered Drug Products’ Dossier

• FDA MEMO CIRCULAR NO. 2013-025

Transfer of Advertisement and Promotion Functions from the Legal Services Support Center to the Other Centers of the FDA

• FDA Memo Circular No. 2013-028 General Guidelines on the Promo Permit Applications and for Other Purposes

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DOH/FDA ISSUANCE

• AO 2013- 0012

Rules and Regulations Governing the Accreditation of Health Facilities in Human Stem Cell and Cell Based or Cellular Therapies in the Philippines

• FDA CIRCULAR NO. 2013-017

Registration of Human Stem Cell-Based Products

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DOH ISSUANCE

• AO 2013-0021 Adoption of the Association of

Southeast Asian Nations (ASEAN) Common

Technical Dossier (ACTD) and Common

Technical Requirements (ACTR) for the

Registration of Pharmaceutical Products for

Human Use

– Published in the newspaper 20 July 2013

– Full implementation by 06 August 2013

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AccomplishmentsAccomplishments

Accomplishments

• Harnessing ICT to Improve Regulatory Efficiency

– Use of FDA E-mail System (Zimbra)

– Upgrading of FDA Website (fda.gov.ph)

Uploading of the list of applications for initial registration

Decking schedule made available

List of registered products (to be further enhanced)

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New FDA Website

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eReport

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Accomplishments

• Launching of FDA Academy – FDA platform for training/retooling FDA Employees,

QPIRA and industry – FDA Internship Program

• QPIRA (Qualified Personnel in Regulatory Affairs) – To ensure correct and complete submission of

marketing authorization dossier, increase work efficiency and improve turnaround time

– To improve information dissemination and communication

– To facilitate e-documentation of all transactions in the future

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Accomplishments

• Initiate BA/BE Studies Capability Building

– BA/BE capability building for Gov’t and Private Hospitals

– Ensure interchangeability

– Philippines as Clinical Trial Center for new drugs

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Field Regulatory Operations Office Re-tooling

• Regional FRO Clusters

• Regional Field Office (RFO)

– Administrative Division

– Licensing, Inspection and Compliance Division

• Regional Enforcement Unit (REU)

• Satellite Laboratories

– Davao and Cebu

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22ndnd semsem 20132013 CommittmentsCommittments

2nd sem Commitments 1. To continue what has been started especially in the review

and updating of regulation ensuring its alignment with the international standards and practices – Regulation on Biosimilars

– Regulation on blood and blood products

– Mexico Principle Declaration (Ethical practices)

– Revision of AO 67 (1989) –Registration guidelines Human and Veterinary drug products

– Good Distribution Practice and Good Storage Practice

– Revision of AO 55 (1988), 85 and 99 (1990 )- Labeling requirements

– Revision of AO 56 (1989) Licensing of establishments

2. To act on all incoming requests (licensing/ registration application and post approval changes within the committed TOT

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2nd sem Commitments

3. To intensify post market surveillance following the risk based approach

• Inspection and product quality monitoring

• Pharmacovigilance

4. Together with PPO, CDRR will conduct training for the:

– Qualified Persons in the Industry Regulatory Affairs (QPIRA) in of Registration of Drug Products

– Licensing of Establishments -

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The way forwardThe way forward

Risk Based Approach to: Drug Product Evaluation

GMP Inspection and Certification

Quality Control Testing

Post Market Surveillance

Upgrading of Testing Facilities Lot Release of Imported Vaccines including laboratory

testing

Quality control testing of Biosimilars eg EPO

Determination of contaminants and other impurities

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WAY FORWARD: REVIEW WORK PROCESSES

WAY FORWARD:

• Market-Driven, Demand-Driven Price Reduction – Drug Outlet Digital Cartography – Google Map: Location of all outlets and Price of

Essential Drugs – Patient can choose: consider the distance from drug

outlet and price – Reduction of Drug Price: lower selling price due to

competition and increase market share (ICT)

• Alignment with NCPAM – Botika ng Barangay – Training of pharm assistanst to dispense health

products in low risks drug outlets (under discussion with PRC/Pharmacist)

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• Greater Focus on Collaboration with other NDRAs

Discussion/Talks with

USFDA/Singapore/KFDA/Malaysia

Joint GMP Audits through JSC

Joint/Collaboration - Evaluation of Dossiers

• PICS Accession

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WAY FORWARD: INTERNATIONAL COLLABORATION/CONVERGENCE

ANNOUNCEMENT

• Forum for Consumer Reporting System - “Bringing Pharmacovigilance Closer to You”

30 July 2013, 1:00-5:00 pm

Vivere Hotel

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THANK YOUTHANK YOU