FDA FDA Updates Updates and Developments and Developments Maria - - PowerPoint PPT Presentation

1

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 1st GMM 2013 26 July 2013

2

Presentation Outline

Presentation Outline

• Regulatory Framework
• Our Vision, Mission, Quality Policy
• CDRR Organizational Structure
• CDRR Strategies
• Regulatory Updates
• Accomplishments
• Commitments for the 2nd sem 2013
• Way Forward

3

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.

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

7

Vision, Mission &

Quality Policy

8

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

• ur competence

to deliver quality public service with integrity

Quality Policy

9

CDRR

Organizational Structure

OFFICE OF THE CENTER OIC LICENSING AND REGISTRATION DIVISION

PRODUCT RESEARCH AND STANDARDS DEVELOPMENT DIVISION

Manufactur ers 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 10

11

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

12

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

13

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)

CDRR MANPOWER COMPLEMENT CDRR MANPOWER COMPLEMENT during transition during transition

Total no. of CDRR personnel Permanent Contractual

74 T- 27 NT- 16 T- 27 NT- 4

14

15

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

16

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

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

21

Regulatory

Regulatory Updates: Updates: DOH/FDA DOH/FDA Issuances Issuances

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

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

29 July 2013 28

FDA ISSUANCES

29 July 2013 29

• 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

30

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)

31

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)

32

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]

33

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

29 July 2013 34

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

29 July 2013 35

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

29 July 2013 36

37

Accomplishments

Accomplishments

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)

29 July 2013 38

New FDA Website

29 July 2013 39

eReport

29 July 2013 40

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

29 July 2013 41

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

29 July 2013 42

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

29 July 2013 43

44

2nd

nd sem

sem 2013 2013 Committments Committments

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

45

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

• 46

47

The way forward

The 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

48

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

• utlet 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)

29 July 2013 49

• 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

50

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

29 July 2013 51

29 July 2013 52

53

THANK YOU

THANK YOU 