Afghanistan Food and Drugs Authority (AFDA)
The development of the Concept Note for National Medicines and Health products Regulatory Authority (NMHRA) has been led by the Ministry of Public Health (MoPH) technical working group which consisted of executives and experts from both inside and outside the Ministry of Public Health (MoPH), including technical officers and health officers from the development partners for health.
The MoPH would like to express our sincere gratitude to the following people who gave us the opportunity to this exciting endeavour to the establishment of NMHRA:
- HE. Dr. Ahmad Jan Naim,
- Dr. Abdul Wali Ghayur,
- Dr. Abdul Hafiz Quraishi,
- Dr. Abdul Majeed Siddiqi,
- Dr. Shafiqullah Shahim,
- Mr. Mohammad Zafar Omari,
- Mr. Hamid Furmuly,
- Dr. Safiullah Nadeeb,
- Mr. Noor Ahmad Zulal,
- Mr. Mohammad Basir
We also would like to extend our thanks to the colleagues in the Presidential Office for fostering the whole process of the development of concept note, the Strengthening Pharmaceutical Systems (SPS) Project for providing technical support, and also to the financial assistance of US Agency for International Development (USAID).
Dr. Ferozuddin Feroz
Minister of Public Health,
Kabul, Afghanistan.
Background
Afghanistan is one of the countries where the quality of pharmaceuticals is always criticized by the public and the end users. Due to long and uncontrolled borders with Pakistan and Iran, large amounts of substandard, counterfeit and illegal pharmaceuticals enter the country. Anecdote evidence shows that huge amounts of medicine manufactured illegally on the other sides of borders exclusively for export to Afghanistan. The medicine through legal trade is required and being tested for quality control, however, those imported illegally has never been screened for quality and also because of lack of resources and inadequate control systems, they are not controlled after marketing in dispensaries.
Pharmaceuticals import is not well regulated, which is mainly been due to lack of political well, in many cases personal interest and nonexistence of dedicated and strong autonomous regulatory authority. Recent data indicate that more than 95% of the medicines imported to Afghanistan are manufactured outside Afghanistan, especially in Pakistan, Iran, India and Middle East. Pakistan may have illicit producers specifically targeting the Afghan market with their pharmaceutical supply. There are more than 1090 pharmaceuticals importing companies registered within Ministry of Public Health, among them around 238 are active. These private importing companies both supply the public and private sectors.
Anecdotal data estimates that the market for smuggled drugs is around 40% to 55% of the total market including the public sector. By law the government allows the importation, production and sale of only approximately 1800 medicines. (Licensed Medicine List), however, in the market there are many items that are not part of this list demonstrating the need for frequently adjusting the lists and also ensure adequate market control.
The fundamental factors of the unsatisfactory status of the current pharmaceutical sector services in Afghanistan is a weak regulatory and management system as a result of parallel organizations with fragmented or insufficient authorities and lack of proper infrastructures and resources for efficient implementation of the rules and regulations. Currently, inspection of companies (manufacturers and importers) is conducted by the Inspection Department of GDPA, but the Health Legislation Implementation Enforcement Directorate (HLIED) and Monitoring and Evaluation Directorate (M&E) conduct the inspection of retail and hospitals/clinics’ pharmacies. In addition, the quality control activities are currently handled by the Medicines and Food Quality Control Directorate (MFQCD). Furthermore, the National Medicine and Food Board (NMFB) serves as an oversight body for the pharmaceutical and food sectors within the MoPH. Thus, several departments of MoPH are involved in regulatory functions in parallel with poor coordination which lead to a poor sector control.
Establishing an independent NMHRA with required financial and human resources, sufficient authority and clear responsibilities will lead to improved Afghans’ access to safe, effective, good quality and affordable medicines and health products.
The purpose of this document is to present the informed discussion and proposal for establishment of an independent autonomous NMHRA by merging the regulatory functions from several related MoPH departments.
Vision, Mission and Objectives
Vision: Availability of safe, efficacious, quality and affordable medicines and health products for all Afghans.
Mission: To ensure access to quality, safe and efficacious medicines and health products through regulation and control of production, importation, exportation, distribution and use.
Objective: To develop and enforce effective standards in order to optimize the safety, efficacy, quality and affordability of medicines and health products throughout the country.
Scope of Work
The scope of the regulatory authority as stated its name will cover medicines and health products as defined by the recently revised Medicines and Health Product Law.
The scope of regulatory authority in terms of geographic and levels of services will cover regulation and control of all premises, practices and processes, within both the public and private sectors, that are engaged in or connected with any aspect of manufacture, promotion, procurement, import, export, distribution, sale, or supply of medicines and health products in Afghanistan.
Functions
The proposed regulatory functions for the NMHRA are:
- Licensing of premises, practices and personnel
- Registration of medicines and health products
- Inspection and enforcement of law and regulation related to medicine and health products
- Quality control & research
- Monitoring on quality, safety of marketed medicine and health products (Pre and Post marketing vigilance.
- Regulation and control of medicines information and promotions (advertisement)
- Pricing and price control
- Regulation and control of clinical trials
- Market authorization and lot release
- Control of narcotic, psychotropic substances and precursors
- Development of legislative and regulatory documents
Governance & Organization (Structure, Accountability and Audit)
The Government of Afghanistan is committed to the principle of good governance as defined by international conventions and national legislation, and is determined to implement governance that is effective, equitable, participatory, accountable, transparent, responsive, and inclusive and that follows the rule of law. To this end, the NMHRA must be committed to the proposed governance principles as detailed in the National Medicines Policy (NMP) and to ensure all the principles of good governance of medicine defined by the WHO are implemented throughout the pharmaceutical sector in Afghanistan2.
In order to streamline the relevant functions of NMHRA, the Governance bodies will function in the following structure:
National Medicine and Health Products Board (Governance Board):
The governance board is chaired by the Minister of Public Health and intended to serve as governance body for the development and implementation of relevant policies and monitoring of the strategic activities of the NHMRA. This board is expected to support both the NMHRA and the MoPH Directorate of Pharmaceutical Services. In addition, this board will also align the efforts between pharmacy directorate and the NHMRA. The board will have its own secretariat and the vice chair, members and subcommittees will be decided by the board as per the Medicine and Health Products Law requirements. In order to ensure transparency, the board will also designate audits and appeal processes, where needed.
In particular the following functions will be carried out by the board:
- Recommends hiring, termination and replacement of the CEO of the NMHRA;
- Approval of all policies, strategies, manuals, guidelines;
- Assisting in advocacy, legal issues and coordination with different government and non-governmental bodies;
- Ensure the integrity of the NMHRA financial and non-financial reporting systems and formally approving and adopting the financial statements and the annual reports;
- Ensuring accountability and transparency of the organization by establishing efficient internal audit mechanism for the organization;
- Approving and providing advice on new initiatives and strategic directions and establishment of board sub committees;
- Overseeing the delivery of the planned results by monitoring performance against the objectives and targets and ensuring corrective action is taken where necessary;
- Ensure the organization complies with any statutory or administrative requirements for the use of public funds and that the board itself operates within the limits of its statutory authority and/or delegated authority;
- Ensure effective communication policy is in place, in relation to both internal and external communications, and that its operation is monitored.
Composition of the board is as following, however, if need for more members; the board will decide during operation based on need:
- Chair Minister of Public Health,
- Representative of Afghan National Standard Authority (ANSA)
- Representative of Pharmacology department of Kabul Medical University
- Representative of Pharmacy Department of Kabul University
- Representative of Veterinary Department of Ministry of Agriculture
- Representative from H.E. President office
- Representative of WHO
- Representative of Afghan National Pharmacists Association
- Representative of Private sector from importing entities )non-voting member)
- Representative from manufacturing entities )non-voting member)
- Representative of Pharmacy Directorate )non-voting member)
- Representative of NMHRA )non-voting member)
The NMHRA:
The proposed structure of NMHRA is developed based on the list of regulatory functions the agency implements. The Chief Executive Director (CED) of the NMHRA is recommended by the board and forwarded to the president for approval. The CED will be accountable and reporting to the board. The NMHRA will have an Executive Committee chaired by the CED to implement the strategic directions, ensure technical excellence, and oversight of the sub-departments. The NMHRA will be consisting of several departments/directorates in accordance with proposed regulatory functions and every department will be headed by a director/manager accountable to the CED of NMHRA.
department will be headed by a director/manager accountable to the CED of NMHRA.
Legal Status (Legislative Document)
In order to fulfill the proposed duties effectively, the NMHRA must be supported by the government to function within an administrative and legal environment. Therefore, the NMHRA will be established by a presidential decree followed by approval the revised Medicines and Health Products Law.
Transition to a National Medicines & Health Product Regulatory Authority
The NHMRA as new body will inherit all the regulatory functions from the GDPA and other MoPH departments. The other non-regulatory function will be fulfilled by MoPH pharmacy directorate and reform of Pharmacy enterprise.
In particular the pharmacy enterprise will be reformed to ensure, procurement, supply and distribution of medicine while the pharmacy directorate of MoPH will carry out the following functions:
- Development of policies, strategies and related guiding procedures at national level
- Promoting the rational medicine uses
- Development and revision of Essential Medicines List (EML), Afghan National Formulary (ANF), and Standard Treatment Guidelines (STGs) etc.
- Pharmaceutical Information Management System (PMIS)
- Pharmaceutical needs planning
- Pharmaceutical human resources capacity improvement by coordination of General Directorate of Humane Resources (GDHR).
- Local manufacturing support
- Coordination with other MoPH departments for better implementation of medicines related health policies
Required Support from Other Ministries
The political and financial supports are vital issues for successful establishment and operation of NMHRA. Therefore, a clear Presidential Decree to support establishment and operation of the authority is highly important to start restructurings and serve as legal base to operate until a
Legal Status (Legislative Document)
In order to fulfill the proposed duties effectively, the NMHRA must be supported by the government to function within an administrative and legal environment. Therefore, the NMHRA will be established by a presidential decree followed by approval the revised Medicines and Health Products Law.
Transition to a National Medicines & Health Product Regulatory Authority
The NHMRA as new body will inherit all the regulatory functions from the GDPA and other MoPH departments. The other non-regulatory function will be fulfilled by MoPH pharmacy directorate and reform of Pharmacy enterprise.
In particular the pharmacy enterprise will be reformed to ensure, procurement, supply and distribution of medicine while the pharmacy directorate of MoPH will carry out the following functions:
- Development of policies, strategies and related guiding procedures at national level
- Promoting the rational medicine uses
- Development and revision of Essential Medicines List (EML), Afghan National Formulary (ANF), and Standard Treatment Guidelines (STGs) etc.
- Pharmaceutical Information Management System (PMIS)
- Pharmaceutical needs planning
- Pharmaceutical human resources capacity improvement by coordination of General Directorate of Humane Resources (GDHR).
- Local manufacturing support
- Coordination with other MoPH departments for better implementation of medicines related health policies
Required Support from Other Ministries
The political and financial supports are vital issues for successful establishment and operation of NMHRA. Therefore, a clear Presidential Decree to support establishment and operation of the authority is highly important to start restructurings and serve as legal base to operate until approval of the revised Medicines and Health Products Law which also requires the Ministry of Justice support to foster it. And finally official process for acquiring budget as regular annual allocation from the Ministry of Finance is the key point to smooth operation of the Authority.
Financing
The NMHRA financial autonomy will be supported by establishing its own bank account for revenue of its incomes which are charged fees for its services, but will be financed through a mixture of fees and government allocations.
The government budget is much needed for initial years since the NHMRA revenue will not be sufficient to cover all expenses. However, if the revenue generated from medicine and health products registration and licensing of practices is sufficient, then the government support could be gradually reduced. In long term, based on other countries experiences it is expected that the NMHRA income will be enough for sustainable financing of the NMHRA.
The annual budget of the NMHRA will be prepared taking into account the balance with the income and will be reviewed and approved by the board and then will be submitted for further process as per designated procedures.
Implementation Plan with Time Frame
|
Proposed Activities |
Responsible |
1394 |
95-98 |
Expected Achievements |
Assumptions |
||||||||
|
M A Q |
95 96 97 98 |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
1.1. |
Finalization of a concept note and comprehensive plan for establishing NMHRA |
|
|
|
|
|
|
|
|
NMHRA established with staffing and office space |
|
||
|
|
1.1.1. |
Provide initial order for establishing NMHRA |
MoPH |
|
|
|
|
|
|
|
|
Consultancy & TWG meetings |
|
|
|
|
1.1.1.1. |
Develop a concept note on NMHRA establishment and a comprehensive plan |
|
X |
|
|
|
|
|
|
|
|
|
|
|
1.1.1.2. |
Finalization of the concept note and the plan with MoPH |
|
|
X |
|
|
|
|
|
|
|
|
|
|
1.1.1.3. |
Submit the concept note and plan to HE president for approval |
|
|
X |
|
|
|
|
|
|
|
|
|
|
1.1.1.4. |
Seek the HE president approval of concept note and achieve president order on establishment of NMHRA and structuring of GD for Pharmaceutical services |
|
|
X |
|
|
|
|
|
|
|
|
|
|
1.1.1.5. |
Appoint an authorized committee to work on detailed restructuring and legal document baking MRA establishment |
|
|
|
X |
|
|
|
|
|
|
|
|
1.1.2. |
Develop and finalization of detailed legal document |
MoPH, |
|
|
|
|
|
|
|
|
Consultancy, TWG meetings, Consultative workshop(s) |
|
|
|
|
1.1.2.1. |
Develop a detailed legal document (including NMHRA conceptual framework, Scope of Work, Line of Communication, TORs of department and Unites etc.) by committee |
|
|
|
X |
X |
|
|
|
|
|
|
|
|
1.1.2.2. |
Conduct a consultative workshop for concensuse building on the proposed structure |
|
|
|
X |
X |
|
|
|
|
|
|
|
|
1.1.2.3. |
Seek approval of proposed structur and passing the legal document by MoJ and council of ministers |
|
|
|
|
X |
|
|
|
|
|
|
|
1.1.3. |
Actual Implementation of NMHRA structuring |
MoPH, |
|
|
|
X |
|
|
|
|
|
|
|
|
|
1.1.3.1. |
Define individual roles and develop job descriptions |
|
|
|
X |
|
|
|
|
|
excludes operating costs e.g. staff salaries; estimate HR requirements 200 people. Recruitment costs 30% of average salary |
|
|
|
1.1.3.2. |
Recruit staff and assign responsibilities. |
|
|
|
X |
X |
|
|
|
|
|
|
|
1.1.4. |
Provide necessary infrastructure and equipment |
MoPH, |
|
|
X |
X |
|
|
|
|
costs are for refurbishing the provided building as oppose to constructing a new structure ; est. 160 office desks |
|
|
|
|
1.1.4.1. |
Provide building for NMHRA |
|
|
|
X |
|
|
|
|
|
est. 1600square meter office space (est 200pple) |
|
|
|
1.1.4.2. |
Provide the required office equipment for NMHRA |
|
|
|
X |
X |
|
|
|
|
|
|
|
1.1.5. |
Seek technical support from World Health Organization |
MoPH |
|
|
X |
X |
X |
|
|
|
|
|
|
|
|
1.1.5.1. |
Provision TA for the MOPH till the NMHRA becomes fully functional |
|
|
|
X |
X |
|
|
|
Provided TA through local and international experts |
|
|
|
|
1.1.5.2. |
Capacity building of the NMHRA staff on the different reg. functions |
|
|
|
X |
X |
|
|
|
Conducted training courses on the different subjects |
|
|
|
|
1.1.5.3. |
TA for the NMHRA for the development of SOPs where is needed |
|
|
|
X |
X |
|
|
|
developed SOPs for the inspection, licensing and etc. |
|
|
|
|
1.1.5.4. |
TA for the NMHRA for the development of Appeals mechanism |
|
|
|
X |
X |
|
|
|
Developed mechanism for Appeal mechanism |
|
|
|
|
1.1.5.5. |
Assisting the NMHRA in conducting a self-assessment (using WHO tool) |
|
|
|
X |
X |
|
|
|
Conducted self-assessment from NMHRA, using WHO Tool |
|
|
|
|
1.1.5.6. |
conducting stakeholders' workshop on NMHRA |
|
|
|
X |
X |
|
|
|
Conducted stakeholders workshop for making consensus |
|
|
|
|
1.1.5.7. |
Conducting Assessment from the NMHRA |
|
|
|
|
|
X |
|
|
Assessed the NMHRA using WHO tool |
|
|
1.2. |
Provide required legitimacy for NMHRA Establishments and Functions |
|
|
|
|
|
|
|
|
Approved Medicines &Health product Law and key regulations |
meetings, workshops, consultancy |
||
|
|
1.2.1 |
Seek support for quick approval of revised Medicines Law |
MoPH, |
|
|
X |
X |
|
|
|
|
Advocacy |
|
|
|
1.2.2. |
Develop and approval of required Regulations, and regulatory guidelines |
MoPH, |
|
|
X |
X |
|
|
|
|
Development of regulations and guidelines is done in phased approach. (est -2 policies, 4 main regulations, 8 main guidelines) |
|
|
1.3. |
Develop structure and system for Pharmaceutical Management Information Systems (PMIS) and communication |
|
|
|
|
|
|
|
|
Functional PMIS system |
Software development, support & training |
||
|
|
1.3.1. |
Improve data use for decision making at all level of the system |
|
|
|
X |
|
|
|
|
|
|
|
|
|
1.3.2. |
Improve Pharmaceutical Registration Information System (PRIS), Pharma HRIS and Pharmaceutical Logistics Information System (PLIS) and roll out nationally |
|
|
|
X |
X |
|
|
|
|
|
|
|
|
1.3.2.1. |
Devise capacity building program to implement PMIS |
|
|
|
X |
X |
X |
X |
X |
|
|
|
|
1.4. |
Provision of opportunities for evaluation and accreditation of PIER and pharmaceutical training curricula in different technical fields |
|
|
|
|
|
|
|
|
PHR strategic framework implemented |
Training costs (local and external) over 5 year period |
||
|
|
1.4.1. |
Implement the PHR strategic framework |
MoPH, |
|
|
|
X |
X |
X |
X |
|
|
|
|
|
|
1.4.1.1. |
Improve knowledge & experience through trainings (pre-service& postgraduate) and appropriate experiential placements |
|
|
|
|
X |
X |
X |
X |
|
|
|
|
|
1.4.1.2. |
Motivate and empower staff to carry out their duties confidently |
|
|
|
|
X |
X |
X |
X |
|
|
|
|
|
1.4.1.3. |
Establish pharmaceutical accreditation in accordance with Pharmacy Council regulations. |
|
|
|
|
|
X |
|
|
|
|
|
|
|
1.4.1.4. |
Identify and sponsor a core set of professionals for various postgraduate courses, fellowships and experiential internships at other policy/regulatory institutes to prepare them for future leadership and management of the NMHRA and Pharmacy Council. |
|
|
|
|
X |
|
|
|
|
|
|
1.5. |
Mobilizing the resource and Political Support |
|
|
|
|
|
|
|
|
Adequate financial resources for the establishment and operations of NMHRA |
Advocacy, publicity (local & international) |
||
|
|
1.5.1. |
Discuss and agree with Ministry of Finance & Economic for collection, remittance and retention of fees accruing through the NMHRA and Pharmacy Council. |
MoPH |
|
|
X |
X |
|
|
|
|
|
|
|
|
|
1.5.1.1. |
Provide mechanism for sustainable financing and advocate with government and donors to secure the required budget |
|
|
|
|
X |
|
|
|
|
|
|
|
1.5.2. |
Provide building and the required office equipment for NMHRA and Pharmacy council |
MoPH |
|
|
X |
|
|
|
|
|
Repetition for NMHRA; NMHRA establishment includes Pharmacy Council |
|
|
|
1.5.3. |
Public education on regulatory functions |
MoPH |
|
|
|
X |
|
|
|
|
|
|
|
|
|
1.5.3.1. |
Share information/updates on pharmaceutical sector developments and challenges regularly with MOPH leadership and general public (media) |
|
|
|
|
X |
|
|
|
|
|
|
|
1.5.4. |
Foster collaboration with local, regional and international organizations for knowledge and information exchange |
|
|
|
|
X |
X |
X |
X |
|
|
|
|
2.1. |
Improve products Registeration and Market Authorizationa Systems |
|
|
|
|
|
|
|
|
All products on the market registered as per the new requirements |
Training |
||
|
|
2.1.1. |
Implement the new registration guideline |
MoPH, |
|
|
|
|
|
|
|
|
|
|
|
|
|
2.1.1.1. |
Reregistration of Marketed products |
|
|
|
X |
X |
|
|
|
|
|
|
|
|
2.1.1.2. |
Registration of new medicines |
|
|
|
X |
X |
|
|
|
|
|
|
|
2.1.2. |
Develop variation guideline |
|
|
|
|
X |
|
|
|
|
repetition - covered under development of guidelines above |
|
|
2.2. |
Improve Pharmaceutical establishments licensing Systems |
|
|
|
|
|
|
|
|
All pharmaceutical establishments licensed |
Training & TWG meetings |
||
|
|
2.2.1. |
Develop system for registration of premises and licensing of pharmaceutical establishments and technical staffs (with SOPs) |
MoPH, |
|
|
X |
X |
|
|
|
|
|
|
|
|
|
2.2.1.1. |
Prepare for Relicensing of pharmaceutical Establishments |
|
|
|
X |
X |
|
|
|
|
|
|
2.3. |
Build institutional and organizational capacity of NMHRA to perform the pre- and post-licensing inspections |
|
|
|
|
|
|
|
|
All pharmaceutical establishment inspected on regular basis |
Consultancy, TWG meetings |
||
|
|
2.3.1. |
Develop inspection manual for inspection |
MoPH, |
|
|
X |
|
|
|
|
|
|
|
|
|
|
2.3.1.1. |
Revision of inspection checklists for pharmaceutical establishments |
|
|
|
|
X |
|
|
|
|
|
|
2.4. |
To ensure quality of medicines in Afghanistan through enhancing the medicines quality control laboratory (MQCL) services at the tier three testing as defined by the National Medicines QA Policy. |
|
|
|
|
|
|
|
|
QC lab ISO 17025 certified |
Refurbishing the QC Lab, Equipment, training, consultancy, meetings/workshops |
||
|
|
2.4.1. |
Upgrade the MQCL to the level that will be certified by the ISO 17025 certification process |
MoPH, |
|
|
|
X |
|
|
|
|
Est. 1600 square meters lab space |
|
|
|
2.4.2. |
Integrate the MQCL into NMHRA and strengthen its organizational capacities |
MoPH, |
|
|
X |
X |
|
|
|
|
|
|
|
|
2.4.3. |
Feasibility analyses for establishing regional QCLs |
MoPH, |
|
|
|
X |
|
|
|
|
|
|
|
2.5. |
To operationalize a market surveillance system to enforce the quality standards including the collection, analysis and detection of quality and safety concerns of pharmaceutical products. |
|
|
|
|
|
|
|
|
Functional PMS system established |
TWG meetings, training, PMS materials, data collection |
||
|
|
2.5.1. |
Finalization of pharmacovillance pilot implementation |
MoPH, |
|
|
|
X |
|
|
|
|
|
|
|
|
2.5.2. |
Develop a national pharmacovigilance policy |
MoPH, |
|
|
|
X |
|
|
|
|
repetition - covered under guidelines above |
|
|
|
2.5.3. |
Expand the pharmacovilance activities to several hospitals |
MoPH, |
|
|
|
X |
X |
|
|
|
|
|
|
2.6. |
Improve the mechanisms to control medicines promotion and advertisement |
|
|
|
|
|
|
|
|
Guideline on control of promotion and advertising approved and implemented |
|
||
|
|
2.6.1 |
Develop a regulatory guideline on control of promotion and advertising |
MoPH, |
|
|
X |
X |
|
|
|
|
|
|
|
2.7. |
Improve the mechanisms to control medicines pricing |
|
|
|
|
|
|
|
|
Pricing of medicines on the market controlled. |
|
||
|
|
2.7.1. |
Develop a medicines pricing policy and guideline. |
MoPH, |
|
|
|
X |
|
|
|
|
|
|
|
|
2.7.2. |
Establish a price control mechanism |
MoPH, |
|
|
|
X |
|
|
|
|
|
|
|
2.8. |
Improve the control of medicines import and release permission |
|
|
|
|
|
|
|
|
Import control system functional |
Meetings/workshop, trainings |
||
|
|
2.8.1. |
Finalize policy for narcotics, Psycotrtopics and controlled medicines |
MoPH, |
|
|
X |
X |
|
|
|
|
repetition - covered under guidelines above |
|
|
|
2.8.2. |
Develop a Guideline for importation of medicines (With SOPs) |
MoPH, |
|
|
X |
X |
|
|
|
|
repetition - covered under guidelines above |
|
|
|
2.8.3. |
Guideline for sampling of medicines (chain of Custody) (with SOPs) |
MoPH, |
|
|
X |
X |
|
|
|
|
repetition - covered under guidelines above |
|
|
|
2.8.4. |
Support the privete sector towards establishing of accreditation system for "good quality" |
MoPH, |
|
|
|
|
|
|
|
|
|
|
Glossary
Audit is the evaluation and assessment of managerial qualities to make sure that resources are used economically and effectively, the capital is safeguarded, financial and all information is reliable; laws, regulations, and policies are abided by; risk management is ensured; and structures, systems, and processes are effective in an administration.
Efficacy is the ability of medicine to produce favorable effects that have been proved by scientific and experimental approaches.
Inspection is the general examination of affairs or activities related to an administrative unit to measure the level of compliance of the unit with standards, good operational methods, and all other disciplines as well as to make recommendations for reforms.
License is a document issued to a special individual, organization, or company to be involved in or facilitate a specific activity as organized by this law and is valid for a specific period of time mentioned therein in compliance with the terms of the National Medicine Regulatory Authority.
Monitoring is an ongoing process through which workers receive feedback in regard to progress toward goals and objectives.
National Medicine and Health Product Regulatory Authority (NMHRA) is the entity responsible for the management, coordination, and monitoring of overall affairs related to medicines and health products to ensure the quality, effectiveness, and safety of medicines and health products in the country.
Pharmaceutical product: Any preparation for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient
Pharmacovigilance (PV): The science of detection, assessment, and prevention of adverse reactions and related problems, as a major resource for ensuring the safe and rational use of medicines.
Quality is compliance of a product with the relevant standards that have been set beforehand.
Quality assurance is a complete and organized system that includes suitable infrastructure, organogram, procedures, processes, resources, and systematic measures required to ensure all necessary qualities of pharmaceutical products.
Quality control comprises all performed activities, including designation of indicators, tests, and analytic calculations, to ensure that raw materials, intermediate materials, packaged materials, and final products are compliant with the specified indicators in regard to identity, strength, purity, and all other descriptions.
Registration of medicines is the process of registering a medicine to certify its sale in the market. It includes assessment of safety, effectiveness, and quality of pharmaceutical products.
Procurement is the collection of required managerial activities required to provide adequate quantities of quality medicine and health products at reasonable prices based on national and international laws in a reliable and timely manner.
Rational medicine use is use of medicine based on clinical needs, in individually required quantities, for an adequate duration of time in compliance with the specific standards and necessary information and available at a reasonable price.
References
1 Ajmal Ahmady’s ( HE President Economy Advisor) presentation to a meeting of HE president with pharmaceutical sector stakeholders
2http://www.who.int/medicines/areas/policy/goodgovernance/en/
Afghanistan National Medicines Policy 2014-2019
National Health and Nutritional Policy 2012 – 2020.
Draft mechanism for the establishment of the FDA in Afghanistan
WHO Effective Drug Regulation (2002) and Functional analysis report of the GDPA.