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Quarantine Service (NVRQS) Republic of Korea organized by NVRQS and KAHPA. By: ABDULLAH DIYO DEPUTY DRUGS CONTROLLER (REG) MINISTRY OF HEALTH GOVERNMENT OF PAKISTAN ISLAMABAD
BY: ABDULLAH ABRO MOH PAK 1
(20) DDG (P) (19) DDC (P) (18) ADG (E&M) (17) ADC (P) (17)
LEGISLATION
Drugs Act, 1976
Regulates import, export, manufacture, storage, distribution and sale and pricing of drugs Rules are framed to regulate licencing, registration, advertising, labelling, packaging, import and export of drugs.
BY: ABDULLAH ABRO MOH PAK 8
FUNCTIONS
Federal Government Provincial Government
13 members including Technical Experts (Directors Drug Testing Laboratories, Professor of Pharmacy, Pharmaceutical Production and Quality Control) Representatives from Ministry of Law and Justice Division. Observers
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Composition
Headed by Director General Health 14 members including Technical Experts (Clinical Physician, Clinical Pharmacologist, Professor of Pharmacy, Animal Husbandry Commissioner, Pharmaceutical Production and Quality Control, Biologicals) Representatives from Ministry of Law and Justice Division. IPO Observers
BY: ABDULLAH ABRO MOH PAK 12
Technical Committees
Technical committees working under Registration Board
Expert Committee on Biological Drugs Expert Committee on Veterinary Drugs
DRUG REGISTRATION
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ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF AN IMPORTED DRUG Dosage Form:------------1. Name and address of the indentor or agent. 2. Name and address of manufacturer of the drug. 3. Brand (Proprietary) name of the drug. 4. The chemical name(s) and , as appropriate and available, the established (generic) and synonyms of the drug. 5. Strength of active ingredient(s) per unit, e.g., each tablet or 5ml, etc. contains.
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6. 7.
8. 9. 10.
Country from where the drug is proposed to be imported. 7- The names of the countries, other than Pakistan, wherever the drug is registered and sold. Specify the brand name(s), if other than the brand name applied for. (Free sale certificate of country of import to be attached.) Pharmacological group. Proposed route of administration. Composition (actives & excepients) including statement of the quantitative composition, giving the weight or measure for each active substance used in the manufacture of the dosage form. Recommended clinical use. Out line of method of manufacture. A full description of the specifications and analytical methods necessary to assure the identity, strength, quality, purity and homogeneity through out the shelf life of the drug product.
BY: ABDULLAH ABRO MOH PAK 19
14. Labeling and prescribing information (to be mentioned on the pack/leaflet) specimen or draft shall be submitted. 15. Proposed dosage. 16. Proposed shelf life of the drug. 17. Unit price of the drug, e.g. per tablet, per capsule, per 5ml, etc. 18. Proposed storage conditions of the finished product. 19. Persons under whose direct supervision and control the drug applied for registration shall be manufactured with the following details, namely: a. total number of technical staff; and b. name, qualification and designation of the persons directly supervising the manufacture of the drug, and any change shall be properly documented and recorded and maintained by the manufacturer.
BY: ABDULLAH ABRO MOH PAK 20
20. Name of equipments that will be used in the manufacture of the applied drug:
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21.Production capacity of the manufacturer per shift for the drug applied. 22.Name, qualification and designation of the persons who will be responsible for the quality control of the drug. 23.Description of the equipment to be used for the quality control of the active raw material and the finished products. 24.Facility of the water processing, with specifications. 25.Environment control processing with details. 26.Attach the last Inspection Report conducted by the concerned Regulatory Authorities. 27.Clinical data (along with data of clinical trials conducted and safety data of the drug, with reported side effects and adverse drug reactions in the indigenous community). 28.Clinical justification. 29.Dosage form stability profile. 30.Any other relevant information that may be required by the Board.
BY: ABDULLAH ABRO MOH PAK 22
UNDERTAKING
I / We hereby undertake that the above given information is true and correct to the best of my
/ our knowledge and belief.
Signature of the authorized importer
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13. Out line of method of manufacture. Complete manufacturing operations from step A to Z in addition to following. a). Master formula b). Manufacturing operation c). Critical steps identified which may change the results d). In process quality control e). Validation of equipments and manufacturing methods etc. 14. A full description of the specifications and analytical methods necessary to assure the identity, strength, quality, purity and homogeneity through out the shelf life of the drug product. Provide complete specification of raw material (both active and non active) and finished drugs for assuring the following: a). Identity of the product b). Strength c). Quality d). Purity e). Homogenacity Protocols of test applied, limits for qualification and its validation is required. (For pharmacopoeial drugs, copies of pharmacopoeial reference of the finished drugs shall be enclosed with the 26 application). BY: ABDULLAH ABRO MOH
PAK
15. Labeling and prescribing information (to be mentioned on the pack/leaflet) specimen or draft shall be submitted. a). Leaflet information Recommended clinical uses, contraindications, side effects, precautions, drug interaction, toxicity, dosage, composition and any other information for the safe and effective use of drug. b). Specimen label and carton as per Drug Labeling Rule 1986. Two packs of finished samples shall also be provided. 16. Proposed dosage. Proposed dosage of the drug (Adults, Children by age group, Infants, Special groups).
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17. Proposed shelf life of the drug. Stability studies including accelerated stability studies in extreme conditions, shelf life, expiry date and storage conditions. 18. Unit price of the drug, e.g, per tablet, per capsule, per 5ml, including pack price of the drug etc. 19. Proposed storage conditions of the finished product. The storage condition shall be derived from the stability studies. 20. Persons under whose direct supervision and control the drug applied for registration shall be manufactured with the following details, namely:(a) Total number of technical staff; and (b) Name, qualification and designation of the persons directly supervising the manufacture of the drug, and any change shall be properly documented and recorded and maintained by the manufacturer.
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21. Name of equipments that will be used in the manufacture of the applied drug: 22. Production capacity of the manufacturer per shift for the drug applied. 23. Name, qualification and designation of the persons who will be responsible for the quality control of the drug. 24. Description of the equipment to be used for the quality control of the active raw material and the finished products. 25. Facility of the water processing, with specifications.
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26. Environment control processing with details including following: a). cleaning validation b). HVAC system c). Maintenance of clean area. 27. Attach the last Inspection Report conducted by the concerned Regulatory Authorities. Inspection report shall be translated in English. 28. Clinical data (along with data of clinical trials conducted and safety data of the drug, with reported side effects and adverse drug reactions in the indigenous community). Data should be specific to the brand and not the molecule. Data include phase I to IV clinical trials. 29. Clinical justification including risk/ benefit ratio, therapeutic superiority over the existing therapy available and cost effectiveness. 30. Dosage form stability profile.
BY: ABDULLAH ABRO MOH PAK 30
31. Free Sale Certificate & G.M.P. certificate (in original) from the regulatory authority in the country of origin as per approved format of the W.H.O. 32. Evidence of Free Sale of applied molecule in any one of the EU countries, USA, Japan and Australia. 33. Sole Agency Agreement with the manufacturer / authorized agent abroad. List of product shall also be attached for which the Sole Agency is given. 34. Information as per guidelines for the registration of biological drugs up loaded on the official website www.dcomoh.gov.pk. (For the application of biological drugs). 35. Original Credentials of the company duly endorsed by the Pakistan Embassy/Consulate office in the country of export. 36. International price comparison (for New Drug) 37. Research papers published in internationally recognized journals. (For New Drug)
BY: ABDULLAH ABRO MOH PAK 31
38. Treasury Challan of Rs. 15000/- (in original) being the registration fee to be deposited in Federal Government treasury under the head of account:C-Non Tax Revenue C02-Receipts from Civil Administration and other Functions C028-Social Services C02841-Health-Other Receipts 39. Four copies of registration dossier/technical data/literature of the drug for Expert Opinion (for new drug). 40. Copy of Drug Sale License. 41. Undertaken by the applicant that same generic having same composition of active ingredient is not already registered with the applicant. Please ensure that the above referred documents/ information complete in all respects, are positively supplied with the registration application. In case of incomplete application, it will be returned to the applicant and considered as disposed off. 32 BY: ABDULLAH ABRO MOH
PAK
National 37 10 03 02 52
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Drugs Act, 1976 and rules under made there under. Central Licensing Board Drug Registration Board Drugs Appellate Board Provincial Quality Control Boards Inspectorate Federal and Provincial Drugs Testing Laboratories Appellate Testing Laboratory Drug Courts
BY: ABDULLAH ABRO MOH PAK 36
Infrastructure
Component Federal Government Main Regulatory Central Body Licensing and Registration Boards Inspectors 12 Drug Testing Laboratories 3 Provincial Governments Provincial Quality Control Boards 238 4
Drug Courts
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BY: ABDULLAH ABRO MOH PAK 37
At the Federal level, Ministry of Livestock & Dairy Development formulates national policies, plans, coordinate/liaison with the Provincial / International organizations such as O.I.E Head / Regional Offices, WHO, regulates animal quarantine and inspection services, assists M/O Health in registration of veterinary drugs & biologics; collection and compilation of livestock statistics for planning national level development programs/projects for the livestock sector.
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Animal Quarantine Department of the Ministry of Livestock & Dairy Development, regulates the import /export of livestock and livestock products through Pakistan Animal Quarantine (Import & Export of Animals and Animal Products) Ordinance, 1979 and Rules 1980. It observes WTO, European Union and trading-partners conditionalities during export of products of animal origin. Animal Quarantine Stations are located at entry and exit points of airports and seaports, ie. Islamabad, Karachi, Lahore, Peshawar, Quetta, Multan and Sialkot. These stations have attached laboratory facilities to conduct basic microbiological diagnostic tests. The quarantine department provides Central Certification Services to importers / exporters of livestock and livestock products.
BY: ABDULLAH ABRO MOH PAK 39
Animal Quarantine Department is involved in registration of slaughterhouses, animal casing and gelatin processing units for export of these commodities. It registers these units in the light of international requirements and carries out regular inspection for pointing out their deficiencies and their rectification to produce livestock products under standard sanitary and hygiene conditions to minimize the chances of contamination in export consignments.
BY: ABDULLAH ABRO MOH PAK 40
National Veterinary Laboratory, Islamabad serves as Reference Laboratory for the diagnosis / research of livestock diseases prevalent in the country. It is also quality assurance laboratory for the export of livestock and livestock products. It provides diagnostic facilities for livestock diseases, carry out sero typing and bio typing of viruses; harmonizes disease diagnostic protocol of Provincial Veterinary Research Institute in conformity with Office International des Epizooties (OIE). It conducts tests for quality assurance for imported / exported and locally produced veterinary vaccines . It carries out drug residue testing on request in food items of animal origin. The veterinary drugs / biologicals are evaluated for their safety, potency and efficacy. It is playing a vital role in human resource development and capacity building. It arranges short term courses of national and international levels regarding new diagnostic techniques and emerging livestock diseases. It also works in close association with the provincial livestock services in analyzing, monitoring, planning and formulation of disease control and eradication programs.
BY: ABDULLAH ABRO MOH PAK 41
The National Reference Laboratory for Poultry Diseases (NRLPD) located at the NARC Islamabad provides diagnostic facilities for poultry diseases, carries out research on local virus isolates and harmonizes disease diagnostic protocol of VRIs / PRIs in conformity with OIE. It is also playing a vital role in human resource development and capacity building. It arranges short term courses of national and international levels regarding new diagnostic techniques and emerging poultry diseases like Avian Influenza. The NRLPD also works in close association with the provincial livestock services in analyzing, monitoring, planning and formulation of disease control and eradication programs.
BY: ABDULLAH ABRO MOH PAK 42
Provincial livestock departments are the executing agencies and focal points for all the livestock activities in the provinces. The provincial livestock departments are divided into Extension Directorate, Breed Improvement Directorate, Animal Health Directorate, Livestock Farm Directorate, Planning Department and Research Directorates. These directorates function in their defined spheres through a net work of field offices at gross root level. The Federal and Provincial veterinary authorities interact with each other periodically.
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Provincial livestock departments have their own set ups generally comprising of Senior level Administrative Staff (DGs/Directors/Project Directors), District level Administrative Staff (DLOs/DDs/Ads), Field Veterinary Officers (V.O) and para-veterinary staff like Livestock Assistants/SA, AI Technicians and Veterinary Compounders etc. Currently, there are 5 DGs and 31 Directors/Project Directors working in provincial Livestock Departments in the country. The district level administrative staff consists of 89 DLOs/DDs and 198 SVOs/ADs. Nearly 2300 field Veterinary Officers are working in different provinces/areas of the country. These field veterinary officers are supported by more than 5400 para-veterinary staff.
BY: ABDULLAH ABRO MOH PAK
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THANKS
BY: ABDULLAH ABRO MOH PAK 45