Importation of Unregistered Drug Products Center for Drug - - PowerPoint PPT Presentation

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Importation of Unregistered Drug Products Center for Drug - - PowerPoint PPT Presentation

May 02, 2023 382 likes •748 views

Republic of the Philippines Department of Health Food and Drug Administration Importation of Unregistered Drug Products Center for Drug Regulation and Research Food and Drug Administration Presentation Outline I. Food and Drug

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Republic of the Philippines Department of Health Food and Drug Administration

Importation of Unregistered Drug Products

Center for Drug Regulation and Research Food and Drug Administration

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I. Food and Drug Administration

  • II. Use of Unregistered Products

III.Issues for Discussion

Presentation Outline

5 May 2015 2

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Republic of the Philippines Department of Health Food and Drug Administration

Food and Drug Administration

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FDA

  • Office under the Department of Health
  • Created in 1963 by virtue of Republic Act 3720

as amended by Exective Order No. 175, and subsequently Republic Act No. 9711

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Legal Bases

  • Republic Act No. 3720 (as amended) – Foods,

Drugs and Devices, and Cosmetics Act

  • Republic Act No. 9711 – Food and Drug

Administration (FDA) Act of 2009

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Legal Bases

  • Republic Act No. 9502 – Universally Accessible

Cheaper Quality Medicines Act of 2008

  • Republic Act No. 7394 – Consumer Act of the

Philippines

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Legal Bases

  • Republic Act No. 6675 – The Generics Act of

1988

  • Republic Act No. 10354 – The Responsible

Parenthood and Reproductive Health Act of 2013

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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

MISSION

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To be an internationally recognized center

  • f

regulatory excellence safeguarding the health of the Filipinos

VISION

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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 competencies in relation to our regulatory function, and to deliver quality public service with integrity.

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Regulatory Framework Elements

  • 1. Licensing/Accreditation of establishments
  • GMP, GDP, GSP, GCP, and GLP
  • 2. Pre-marketing assessment
  • Quality, safety, and efficacy (for innovative medicines)
  • Quality+interchangeability (for generics)
  • 3. Post-marketing surveillance
  • Safety (benefit/risk balance)
  • Quality (quality testing and compliance monitoring)
  • 4. Communication

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  • 1. 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;

  • 2. Monitoring, collecting, sampling and testing of drugs
  • 3. Audits

and inspection

  • f

manufacturers/ distributors/ retail outlets

  • 4. Advertisements and claims monitoring
  • 5. Consumer reporting of ADR
  • 6. Product recall / Administrative sanctions

Post-Marketing Surveillance

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Republic of the Philippines Department of Health Food and Drug Administration

Use of Unregistered Products

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k), Section 7, amending Section 11 of RA 3720

  • Prohibited acts:

Executive Order No. 175

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  • FDA recognizes the need for drugs and

devices product/preparation which are not registered or are in the process of registration in the Philippines by patients who are terminally or seriously ill.

  • Access to these products for these patients

is morally, socially and ethically justified when there is no existing superior alternative therapy that can likely cure or adequately control their conditions.

5 May 2015 15

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Administrative Order No. 4 s. 1992

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AO No. 4 s. 1992

Compassionate Special Permit for Restricted Use

  • f Unregistered Drug and Devices Product (CSP)
  • a special permit signed by the FDA Director

granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.

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AO No. 4 s. 1992

  • For patients suffering from the following

conditions:

  • 1. Acquired Immune Deficiency Syndrome (AIDS)
  • 2. Cancer
  • 3. Life-threatening conditions

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Application shall include:

  • estimated volume needed
  • the licensed drug/ device establishment through

which the unregistered drug may be procured

  • identify the names and address of the specialists

qualified and authorized to use the product

AO No. 4 s. 1992

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Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total Colistimethate Na 1 M Unit vial 7600 37170 44770 13 23 36 Dipyridamole 10mg/2ml ampoule 10333 16382 26715 12 18 30 Glyceryl trinitrate 10mg/10ml amp 14990 9319 24309 8 20 28 Protamine sulfate 50mg/5ml vial 11475 6691 18166 13 22 35 Vasopressin 20 units/ml vial 4425 6895 11320 10 14 24 Adenosine 6mg/2ml vial 3963 5605 9568 15 30 45 Phenylephrine 1% 10mg/1ml vial 2700 4985 7685 9 17 26 Papaverine HCl 30mg/ml, in 2ml vial 1495 2908 4403 8 19 27 Esmolol HCl 10mg/ml, in 10 ml vial 1405 2958 4363 10 21 31 Milrinone lactate 10mg vial 2302 2057 4359 10 14 24 Dantrolene sodium 20mg/65mL vial 408 850 1258 11 20 31

Top Requested Drugs

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Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Sotalol 80mg tablet 10400 13030 23430 2 2 4 Propafenone 150mg tablet 4400 14500 18900 1 2 3 Liothyronine (Cynomel) 25mcg tablet 7220 7800 15020 4 4 8 Co-trimoxazole (Trimethoprim 16 mg/ml + Sulfamethoxazole 80 mg/ml) [Bactrim] Solution for injection, in 5ml vial 1450 9112 10562 3 8 11 Fludrocortisone 0.1mg tablet 3100 5800 8900 2 4 6 Provocholine nebulization kit 1700 3400 5100 2 2 4 Provocholine 100mg/vial 288 475 763 2 2 4

Top Requested Drugs

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Hospitals

  • No. of applications per year

2013 2014 Total

  • St. Luke's Medical Center – Global City

6 12 18

  • St. Luke's Medical Center – Quezon City

8 8 16 Cardinal Santos Medical Center 8 7 15 The Medical City 5 7 12 Philippine General Hospital 7 3 10 Makati Medical Center 3 6 9 University of Santo Tomas Hospital 2 6 8 Asian Hospital and Medical Center 2 5 7 Manila Doctors Hospital 2 5 7 Philippine Heart Center 2 2 4

Top Requesting Hospitals

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  • Regular request (from 2 to 12 times a year)

for permit to import of unregistered to be used for critical care, strictly for their own use

  • Quantity is considered to be substantial
  • Misalignment with the intentions of AO 4 s.

1992 – no specific patients identified

Conclusions

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Republic of the Philippines Department of Health Food and Drug Administration

Issues for Discussion

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  • Pending Applications
  • Compliance to Clinical Reports
  • Registered counterpart

Issues for Discussion

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  • 19 applications on hold submitted from 24

February to 31 March 2015

Pending applications

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Pending applications

CONTROL NUMBER DATE RECEIVED NAME OF COMPANY PRODUCT

1 2015022416455 1 24-Feb-15 Adventist Medical Center - Bacolod Thiopental sodium 500mg powder for Injection 2 2015022416473 8 24-Feb-15 Makati Medical Center Methoxsalen (GEROXALEN 10mg capsule; Fludarabine (FLUDARA) 50mg vial 3 2015022416412 7 24-Feb-15 De La Salle University Medical Center Protamine sulfate 50mg/ ml w/ 4 drug products 4 2015022416455 1 24-Feb-15 Adventist Medical Center - Bacolod Phenylephrine 1% 10mg/ 1ml ampoule; Colistimethate sodium (COLOMYCIN) 1Million Unit Vial

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Pending applications

CONTROL NUMBER DATE RECEIVED NAME OF COMPANY PRODUCT

5 201502241643 37 24-Feb-15 Mary Mediatrix Medical Center Dipyridamole (PERSANTIN) 10mg/ 2ml ampoule 6 201502261308 42 26-Feb-15 Perpetual Succour Hospital Dipyridamole (PERSANTIN) 10mg/2ml ampoule 7 201502261305 20 26-Feb-15 University of Santo Tomas Hospital

Sulfamethoxazole (SMZ) 400mg + Trimethoprim (TMZ) 80mg (BACTRIM) 5ml ampule

8 201503031238 57 03-Mar-15 Davao Doctors Hospital Fludrocortisone acetate 100mcg tablet 9 201503041220 28 04-Mar-15

  • St. Luke’s Medical

Center Dantrolene sodium 20mg/ 70ml vial w/ 25 drug products 10 201503050923 09 05-Mar-15 Chinese general Hospital and Medical Center Glyceryltrinitrate (NITRONAL) 1mg/ ml, 10ml ampoule; Colistimethate sodium (COLOMYCIN) 1 million Unit Vial

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Pending applications

CONTROL NUMBER DATE RECEIVED NAME OF COMPANY PRODUCT

11 20150312102502

12-Mar- 15 Cardinal Santos Labetalol 100mg/ 20ml vial 12 20150316133902 16-Mar- 15 The Medical City Nicotine TDS Patch 21mg 14ct; Nicotine TDS Patch 14mg 14ct; Nicotine TDS Patch 7mg 14ct; Nicorette Freshfruit 4mg; Nicorette Freshfruit 2mg 13 20150317103602 17-Mar- 15 Asian Hospital and Medical Center Gebauer’s Pain Ease 14 20150324130448 24-Mar- 15 AUF Medical Center Milrinone Lactate Injection 10mg/ vial w/ 4 drug products 15 20150324101744 24-Mar- 15

  • St. Luke’s Medical

Center Methylene blue (PATENT BLUE V) 2mg/ ml

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Pending applications

CONTROL NUMBER DATE RECEIVED NAME OF COMPANY PRODUCT

16 201503241013 08 24-Mar-15

  • St. Luke’s Medical

Center Cyclosporine SANDIMMUNE 50mg vial 17 201503241310 03 24-Mar-15 Jecson Medical Center Dipyridamole (PERSATIN) 10mg/ 2ml Solution for infusion/ Intravenous/ Ampule 18 201503241313 23 24-Mar-15 Cebu Doctor’s Univerrsity Hospital Persantin 10mg/ 2ml ampule 19 201503311636 245 31-Mar-15

  • St. Luke’s Medical

Center Vasopressin (PITRESSIN) 20 units/ ml w/ 22 drug products

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  • Low compliance to reporting
  • PMS is compromised

Compliance to Clinical Reports

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Registered Counterpart

Rho(D) Immune Globulin Intravenous Human (WINRHO SDF) 1500 IU (300mcg) per 3ml, lyophilized powder for injection, in vial BR-681 Johnson & Johnson (Phils), Inc Adenosine (Adenocor) 6mg/2ml vial DR-XY41332 International Apex Pharmaceuticals, Inc. DR-XY43539 SRS Pharmaceuticals

  • Phils. Inc

Esmolol HCl (Brevibloc) 10mg/ml, in 10 ml vial DR-XY42945 International Apex Pharmaceuticals, Inc. Co-trimoxazole (Trimethoprim 16 mg/ml + Sulfamethoxazole 80 mg/ml) [Bactrim] Solution for injection, in 5ml vial DR-XY44038 International Apex Pharmaceuticals, Inc. Thiopental sodium 500mg Powder for Injection Solution, in Vial DRP-5547 Ambica International Trading Corp Labetalol HCl injection 100mg/20ml vial DR-XY43857 International Apex Pharmaceuticals, Inc. Verapamil HCl 2.5mg/ml ampoule DR-XY43909 Abbott Laboratories (Philippines)

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Registered Counterpart

Fludarabine (Fludara) 50mg vial DR-XY26134 Sanofi-Aventis Philippines, Inc Azacitidine 100mg vial DR-XY41608 Invida Philippines, Inc Cinacalcet HCl (Mimpara) 30mg tablet DR-XY43911 DeGa International Pharma Corp Cinacalcet HCl (Mimpara) 60mg tablet DR-XY43910 DeGa International Pharma Corp Potassium Iodide (Jodid) 100mcg tablet DR-XY32533 Merck, Inc.

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  • Use of registered products and consider

therapeutic alternatives

– New policy and NDAC

  • Mandatory registration will be required for

the products

– MAH will have prioritized review – Separate meeting for local counterparts of MAH and other importers

Recommendations

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