Republic of the Philippines Department of Health Food and ... · Melody M. Zamudio, RPh, MGM-ESP Regina S. Obligacion, RPh Grace L. Medina, RPh, MBA/PA. CDRR MANPOWER COMPLEMENT Total

Republic of the PhilippinesDepartment of Health

Food and Drug Administration

KAPIHAN AT TALAKAYANCENTER FOR DRUG REGULATION AND RESEARCH

27 March 2015FDA Annex Building

1. New Organizational Structure

2. New Citizens Charter

3. CDRR Activities

4. Updates on Regulations

5. Target Regulations for 2nd Qtr 2015

6. Regulatory Challenges

Presentation Outline

2



NEW ORGANIZATIONAL STRUCTURE

3

4

FOOD AND DRUG ADMINISTRATIONOrganizational Structure

*Based on RA 9711

Director-General*

Deputy Director-General*for Administration and Finance

Deputy Director-General*for Field Regulatory Operations

Policy and Planning Service

Legal ServiceAdministrative & Finance

ServiceSouth Luzon FO(NCR, IV-A, IV-B, V)

Mindano West FO(IX, XII, ARMM)

North Luzon FO(CAR, I, II, III)

Visayas FO(VI, VII, VIII)

Policy Formulation & Program

Implementation

Monitoring and Evaluation Division

Investigation Division

Litigation & Enforcement

Division

Human Resource Development

Division

Inf ormation & Communications

Technology Mgt. Div .

Budget and Mgt. Division

Accounting Divison

General Services Division

Center for Device Regulation & Radiation Health & Research

Center for Food Regulation and Research

Center for Cosmetics Regulation and Research

Center for Drug Regulation and Research

Product Licensing and Registration

Division

Product Research & Stds. Dev't. Div.

Radiation Regulation Division

Physics Laboratory


Division



Division



Division


Common Services Laboratory

Policy Dissemination and Training Division

Mindano East FO(X, XI, CARAGA)

Administrative and Finance Division

Establishment Licensing, Inspection

& Enf orcement Div ision











Davao Testing & Quality Assurance

Laboratory

Alabang Testing & Quality Assurance

Laboratory

Cebu Testing & Quality Assurance

Laboratory



CDRR ORGANIZATIONAL CHART

5

CDRR

PRSDD

Standards Devt/

Advocacy

Clinical Research

PMS

Drug Safety/PV

SSFFC

PRC

LRD

Licensing

L1

RONPD &

DS

L2

DM

DD

CRO

Sponsor

Registration

Human Drugs

CMC

Clinical

TM/H/

OTCBio/Vacc Vet PAC

Pre-evaluation

Melody M. Zamudio, RPh, MGM-ESP

Grace L. Medina, RPh, MBA/PARegina S. Obligacion, RPh

CDRR MANPOWER COMPLEMENT

Total CDRR

personnel

Technical

Personnel

Non

technical

Personnel

84 56 28

6



7

NEW CITIZENS CHARTER

Type of Application Duration of Activity

Licensing of drug establishment 30 calendar days

Initial application 254 calendar days

Renewal application 68 calendar days

Automatic Renewal application 33 calendar days

CLIDP application 31 calendar days

Variation application 52 calendar days

Certificate of Pharmaceutical Products (CoPP)

14 calendar days

Certificate of Free Sale 14 calendar days

Export Certificate 14 calendar days

Sales Promotion and Ads Permit 14 calendar days

New Citizen’s Charter

8



9

CDRR ACTIVITIES1st QTR 2015

• ASEAN TMHS National Consultation

• CDRR Retooling

• AO 2014-0034 cascading to FROO

• BA/BE Training

• Focus Group Discussion – Fee Restructuring

CDRR Activities10

ASEAN TMHS Consultation - Luzon

• Held 05 January 2015 at FDA AVR Annex11

ASEAN TMHS Consultation – Visayas

• Held 17 March 2015 at RO VII Conference 12

ASEAN TMHS Consultation – Mindanao

• Held 18 March 2015 at Grand Regal Hotel Davao 13

ASEAN TMHS Consultation –

Collation of Feedback

14



• Seeking comments and feedbacks from stakeholders through the consultation template

• Deadline of sending of comments via mail: 15 April 2015

15



• Consultation Template

16

CDRR Retooling

17

CDRR Retooling

• Licensing Section – 3-5 February 2015

• Registration Section and PRSDD – 4-6 February 2015

18

CDRR Retooling

• Licensing Section Objective:

– Review of the implementation of AO 2014-0034 and its IRR

• Registration Section and PRSDD Objective:

– Review of the implementation of recently issued regulations

– Process mapping

19

AO 2014-0034 Cascading 20

• 9-10 February 2015

• Cascading of AO 2014-0034 and review of its implementation to the officers of the FDA Regional Offices

AO 2014-0034 Cascading 21

BA/BE Training22

• Capacity building for industry and FDA staff

• Training conducted by former US FDA staff and USP Scientists:

– Dr. Leonel M. Santos, PhD

– Dr. Vinod P. Shah, PhD

BA/BE Training23

• Two day training for industry participants (16-17 February 2015

• One day training for CDRR Registration staff (18 February 2015)

• One day training for Drug Laboratory staff (19 February 2015)

• Meeting with FDA staff (20 February 2015)

BA/BE Training24

Focus Group Discussion –Fee Restructuring

25

Focus Group Discussion –Fee Restructuring

• Stakeholder associations’ representatives were consulted for the 2015 CDRR proposed fees

• Focus group discussion in preparation for the public hearing to be held in May 2015

• Draft of FDA Fees and Charges will be posted 2nd week of April

• Proposed fees:

26

General Considerations• Business Plan

– Financial sustainability through retention of income

– Reduce impending funding shortfall

– Facilitate implementation of strengthening measures and activities

• Inflation from 2003-2014*

• Growth in the number of establishments and products registered**

27

Considerations -Licensing Fees

• Drug Establishments – no SME classification

• Cover inspection fees once a year for every valid year

• Validity changes:

– Initial: from 1 year to 2 years

– Renewal: from 2 years to 3 years

• From amendment to variations:

– Major, Minor-Prior Approval, Minor-Notification 28

Considerations -Registration Fees

• New drug classification:

– Investigational Product*

– New Chemical Entities

– Generic Products

– Biotechnological Products

– Other class: OTC, Veterinary, TM, HR, Medical Gas

• One-step submission – quality and clinical/non-clinical review (streamlined process)

29

Considerations -Registration Fees

• Cover PMS fees (sampling and lab testing*) throughout the validity

• From amendment to variations:

– Major, Minor-Prior Approval, Minor-Notification

30

Inclusions -Licensing Fees

• Inflation adjusted licensing fees from 2001

• Inspector’s fee + TEV

• Indirect Costs*

31

Inclusions -Registration Fees

• Inflation adjusted registration fees from 2001

• Clinical/non-clinical review including post-marketing commitments

• Brand name evaluation and acceptance

• PMS sampling and laboratory analysis

• Indirect Costs*

• For IPs – inclusive of Protocol review, ERB/ERC review

32

Inflation adjusted Licensing Fee per year for 2 years

+ Inspector’s Fee

+ TEV

+ Indirect Costs

Example: Initial Distributor Licensing Fee

33

License to Operate

34

Category

Fee (in PhP)

Initial

(2-year

validity)

Renewal

(3-year

validity)

Variation

MaV MiV-PA MiV-N

Drug Manufacturer

(Repacker, Packer,

Trader)

100,000 150,000 9,500 1,100 1,100

Drug Distributor

(Exporter, Importer,

Wholesaler)

28,000 42,000 4,400 1,100 1,100

Drugstore/Pharmacy/B

otica and similar outlets

6,400 9,500 2,800 1,100 1,100

Retail Outlet for Non-

Prescription Drugs

(RONPD)

6,400 9,500 2,800 1,100 1,100

Sponsor/Contract

Research Organization

28,000 42,000 4,400 1,100 1,100

Inflation adjusted MR Fee for 5 years

+ Inflation adjusted NCE review

+ Post Marketing Commitments Review (from PMS protocol review fee)

+ Brand Name Acceptance+ 2 proposed Brand Names

+ Inflation adjusted lab testing fee

+ Sampling Costs

+ Indirect Costs

Example: NCE

35

Product Registration

36

Category

Fee (in PhP)

Initial

(5-year

validity)

Renewal

(5-year

validity)

Variation

MaV MiV-PA MiV-N

New Chemical Entity

(NCE)

210,000 66,000 64,000 6,300 1,100

Generic Drugs 97,000 66,000 64,000 6,300 1,100

Biotechnological

Products

237,000 86,000 64,000 6,300 1,100

Other Drug Product

Classification

97,000 66,000 64,000 6,300 1,100



37

CDRR ACCOMPLISHMENTS and

UPDATES

SUMMARY

38

Application Type No. of applications

received

No. of applications

processed

Backlog

LTO & other relatedrequests

6,846 3,899 2,947

CPR & other related requests

14,136 2,558 11,578

LATEST DECKING SCHEDULE

39

PRODUCT SCHEDULEInitial (Rx) Oct 2013Initial (HR-OTC) Oct 2013Monitored Release Oct 2013Automatic Renewal Dec 2014 (12/15)Renewal Apr 2014Monitored Release Extension

Apr 2014

PCPR Dec 2014CLIDP Dec 2014Revalidation UPDATED

LATEST DECKING SCHEDULE

40

PRODUCT SCHEDULEVariation (Others) Jul 2014Variation (SLE-SC) Aug 2014Variation (MiV-PA02) Jul 2014Variation (MiV-N01-10) Oct 2014Compliance Dec 2014PROMO UPDATEDCertification UPDATEDGLE UPDATEDVaccine (Initial & MR) Sep 2014Vaccine (Var-R-MRE) Nov 2014Veterinary Group May 2014



UPDATES ON REGULATIONS

41

• FDA Circular – 7

2014-2015 CDRR Issued Regulations

42

FDA Circular No. 2014-025

43


44


45


46


47

FDA Circular No. 2014-025 to 026 and 2015-003

• Implementing rules and regulations of AO 2014-0034 for Drugstores, Drug Distributors, Drug Manufacturers, RONPDs, and Sponsors and CROs

48

FDA Circular No. 2015-001 and its amendment

49


50


• Clarification on the similarity of PCPR and CLIDP

• PCPR and CLIDP must be identical/similar following the definitions provided under AO 2005-0031

• Submission of appropriate variation applications until 31 December 2015

• Denial of incoming initial applications of CLIDP that are not compliant 51



Target Regulations2nd Quarter 2015

52

1) LTO Format

2) Labeling Requirements

3) Risk Management Plan for Establishments

4) Licensing of Health Facilities Engaged in the Manufacture and Distribution of Medical Gases

5) Expedited Review of Prequalified Vaccines and WHO Collaborative Review Procedure

6) Fees and Charges

7) Q4 of 2015 – New Registration Guidelines

Targets53



54

REGULATORY CHALLENGES

1. Misalignment of 1st yr DBM-approved staffing pattern against requested number and workload/expected output

2. Staff turn-over

3. Influx of applications w/o overseas GMP audit/poor GMP compliance

Challenges55

4. Increased demand for administrative and logistical support to operations– Lack of resources (computers)

– Needs stronger IT infrastructure

5. Increased demand for training and advocacy given the effects of harmonization and globalization, e.g., biosimilars, non-biologic complex drug (NBCD) products, radiopharmaceuticals, and Human Cells, Cellular and Tissue-based products (HCTPs)

Challenges56

Major Deficiencies Encountered

• Non-compliance to AO 2013-0021 (ACTD/ACTR Adoption):

– Not in ACTD/ICH-CTD Format

– Lacking Part (I, II, III, or IV)

• Non-compliance to AO 2013-0022 (Foreign GMP):

– No submitted application of foreign GMP evidence

57

Other Deficiencies Encountered

Noncompliance to FMC 2013-033 and FMC 2014-001 (Conversion to E-copy), and Memorandum on E-copy submission for compliance, revalidation, and re-applications:

• Corrupted files

• Empty folders

• Failure to submit e-copy of old files

58



59

CONCLUSION

Conclusion

The CDRR still commits to

1. Reduce the backlog to 10% hoping for a more robustIT infrastructure, additional personnel and provisionof more desktops or laptops

2. Given the right resources, the CDRR is committed tospeed up the processing of applications

3. Continue working on the policies to provide clarity toour work process

60

THANK YOU!

Documents

Republic of the Philippines Department of Health Food and ... · Melody M. Zamudio, RPh, MGM-ESP Regina S. Obligacion, RPh Grace L. Medina, RPh, MBA/PA. CDRR MANPOWER COMPLEMENT Total