1 PAR Seminar, 3 October 2002
Valerio Reggi, Eshetu Wondemagegnehu
HTP/EDM/QSM - 3 October 2001
WHO - EDM

• Rationale for state role
• Key elements of legislation
• Key elements of regulatory
• Regulation and public health
WHO - EDM
2 PAR Seminar, 3 October 2002

Drug legislation and regulation
Rationale for state role
Key elements of drug legislation
Key elements of drug regulatory system
Drug regulation and public health
3 PAR Seminar, 3 October 2002
WHO - EDM

Rationale for state role
Regulation in medicine is 4000 years old
Hammurabi's Code of Laws (~ 2000 BCE):
 physician fees adapted to patient’s status:
215. …a physician …… shall receive ten shekels in money.
216. If the patient be a freed man, he receives five shekels.
217. If the patient be the slave …… two shekels.
 sanctions for malpractice:
218. If a physician make a large incision with the operating knife and kill the patient or …. … cut out the eye, his hands shall be cut off.
WHO - EDM
4 PAR Seminar, 3 October 2002

Rationale for state role
Essential state functions in the pharmaceutical sector
WHO - EDM
5 PAR Seminar, 3 October 2002

Rationale for state role
Essential state functions in the pharmaceutical sector
 Policy making, priority setting: what are the problems? how do we address them? how do we know what we have achieved?
 Regulation & control: what are the rules? are the rules respected? do we need to change rules?
 Professional standards: who is allowed to do what?
 Access to drugs : can people use the drugs they need?
 Information : can people use drugs properly?
WHO - EDM
6 PAR Seminar, 3 October 2002

Market failure:
 Equity : who cares for the poor? Public/private mix
 Information imbalance
: access to and capacity to assess and compare information on quality, safety, efficacy, value for money, appropriateness
 External benefits
: immunizations and treatment of contagious diseases benefit all, if left to market laws alone many will not be immunized or treated
 Failure of competition : who can develop new drugs? who can influence prescription/consumption? who takes the less profitable activities? competition based on product differentiation rather than price
 Market asymmetry: who pays does not choose, who chooses does not pay
WHO - EDM
7 PAR Seminar, 3 October 2002

Dr. Gro Harlem Brundtland
Director General
“…. drugs are a public good and not simply just another commodity: first for their high social value, and then because consumers and prescribers are unable to assess their quality, safety and efficacy.”
WHO - EDM
8 PAR Seminar, 3 October 2002

Rationale for state role
Selection of essential drugs is a two-step process:
1 - market approval of a pharmaceutical product on the basis of efficacy, safety and quality. This regulatory decision defines the availability of the drug in the market.
2 - most public drug procurement schemes have mechanisms to limit procurement or reimbursements to certain drugs. For these decisions an evaluation is necessary, based on a comparison between various drug products and on considerations of “value for money”.
9 PAR Seminar, 3 October 2002
WHO - EDM

Rationale for state role
The reality (or the paradox) :
- only richer countries make use of this second selection step, and therefore enact mechaisms to rationalise consumption and keep expenditure under control,
- in poorer countries, where health insurance mechanisms are not fully developed and people pay most drug out of pockets, there ar no adequate mechanisms to protect consumers
10 PAR Seminar, 3 October 2002
WHO - EDM

Rationale for state role
In industrialized countries regulatory work takes place in an environment characterized by longer-established regulatory traditions. In addition, there is a relatively mature interaction of interests, actions, and views of regulators, industry with different focuses
(innovative medicines, generics, OTC products,
‘alternative’ medicines), professionals, patient and consumers groups, and individuals.
WHO - EDM
11 PAR Seminar, 3 October 2002

Rationale for state role
In developing countries regulation is often less consolidated than in industrialized countries, and the interaction between the different interested parties is not always balanced. In addition, the resources that can be made available for the implementation of regulatory work and control are not always adequate for the task that regulatory authorities are expected to undertake. This puts special responsibility and burden on decision makers and regulatory officials of developing countries.
WHO - EDM
12 PAR Seminar, 3 October 2002

Rationale for state role
Consequences of weak drug regulatory capacity
WHO - EDM
13 PAR Seminar, 3 October 2002

Drug legislation and regulation
Rationale for state role
Key elements of drug legislation
Key elements of drug regulatory system
Drug regulation and public health
14 PAR Seminar, 3 October 2002
WHO - EDM

Key elements of drug legislation
Purposes of drug legislation

Distinguish “permissible” or “lawful” from
“impermissible” or “unlawful”
 Specify rights, duties, powers
 Provide a legal basis for regulation
 Specify sanctions and penalties to be imposed upon those who violate legislation or regulations.
WHO - EDM
15 PAR Seminar, 3 October 2002

Key elements of drug legislation
Scope of drug legislation
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What products should be regulated
What companies/institutions should be regulated
What activities should be regulated
To what extent should the above be regulated
Who should be responsible for regulation
What sanctions should apply in case of violations
WHO - EDM
16 PAR Seminar, 3 October 2002

Key elements of drug legislation
Items of drug legislation (1)

Technical aspects (title, date of operation, areas of application/exclusion, relationship to other existing laws, transitional arrangements).

Definitions of terms and concepts

Statutory powers (right of inspection), duties and responsibilities of the regulatory authority, and its organization and resources

Requirement for company and product licensing and duration of validity of licences
WHO - EDM
17 PAR Seminar, 3 October 2002

Key elements of drug legislation
Items of drug legislation (2)

Special issues: e.g. patents, prices, clinical trials, post-marketing surveillance, conflicts of interest, access to information, advertising and promotion

Enforcement procedures, penal provisions, and administrative penalties

Right of complaint and appeal against regulatory decisions

Scope and power of regulation-making (i.e. main text must authorize that additional provisions are made through regulations)
WHO - EDM
18 PAR Seminar, 3 October 2002

Key elements of drug legislation
Definitions in drug legislation (1)
Products subject to legislation:
• clear, unambiguous, comprehensive definition of medicinal product:
Any substance or pharmaceutical product for human or veterinary use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient.
WHO - EDM
19 PAR Seminar, 3 October 2002

Key elements of drug legislation
Definitions in drug legislation (2)
“Borderline” products: criteria and attitudes change, new problems arise
•
• flexibility to enable DRA to cover specific classes of product to be within scope of law public health approach demands that
WHO - EDM
20 PAR Seminar, 3 October 2002

Key elements of drug legislation
Definitions in drug legislation (3)
The term "medicinal product" must include, at least: pharmaceutical, biological (vaccines, blood products, other biologicals) and herbal products, including traditional medicines (not harvested by traditional medicine practitioners and sold in package form), products known in many countries as "pharmafoods",
"nutriceuticals", or "cosmeceuticals" intended for therapeutic use and whether for animal or human use.
WHO Expert Committee on Specifications for Pharmaceutical
Preparations. 1998, WHO Technical Report Series, No.885
21 PAR Seminar, 3 October 2002
WHO - EDM

Key elements of drug legislation
Definitions in drug legislation (4)
The drug regulatory authority must also determine to what extent it intends to exempt related products, such as diagnostic materials, medical devices, cosmetics, health foods and food supplements from its scope of issuing marketing authorizations.
……... In borderline cases it might be left to the regulatory authority to decide whether a substance or preparation is considered as a medicinal product.
WHO Expert Committee on Specifications for Pharmaceutical
Preparations. 1998, WHO Technical Report Series, No.885
WHO - EDM
22 PAR Seminar, 3 October 2002

Key elements of drug legislation
Definitions in drug legislation (5)
Activities subject to legislation:
The legislation must apply to all institutions and individuals, within both the public and private sectors, that are engaged in, or connected with any aspect of manufacture, promotion, procurement, distribution, sale or supply of medicinal products.
WHO Expert Committee on Specifications for Pharmaceutical
Preparations. 1998, WHO Technical Report Series, No.885
WHO - EDM
23 PAR Seminar, 3 October 2002

Key elements of drug legislation
Definitions in drug legislation (6)
Statutory powers in legislation: primary responsibility of the national drug regulatory authority is to operate a system of administration and enforcement intended to achieve the objectives of the
Preparations. 1998, WHO Technical Report Series, No.885
WHO - EDM
24 PAR Seminar, 3 October 2002

Key elements of drug legislation
Definitions in drug legislation (7)
Statutory powers in legislation:
A department of veterinary services or a department dealing with traditional medicine practices may exert administrative oversight of services without exercising regulatory control over the products used within the specific discipline.
……… ensure close and effective coordination between all concerned parties.
WHO Expert Committee on Specifications for Pharmaceutical
Preparations. 1998, WHO Technical Report Series, No.885
WHO - EDM
25 PAR Seminar, 3 October 2002

Drug legislation and regulation
Rationale for state role
Key elements of drug legislation
Key elements of drug regulatory system
Drug regulation and public health
26 PAR Seminar, 3 October 2002
WHO - EDM

Key elements of drug regulatory system
Drug regulation comprises all the legal, administrative
& technical arrangements meant to ensure that:
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 all premises, persons & practices engaged in the development, manufacture, importation, exportation, wholesale, supply, dispensing & promotion of drugs comply with approved standards, norms, procedures and requirements drug products are safe, effective and of acceptable quality product information is unbiased, accurate and appropriate drugs are available drugs are used rationally
27 PAR Seminar, 3 October 2002
WHO - EDM

Key elements of drug regulatory system
Basic functions in drug regulation (1)



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Licensing of manufacturers, importers, distributors, wholesale and retail outlets
(premises, persons and practices)
Marketing authorization for drug products
Quality control laboratory testing
Provision of drug information and monitoring of drug promotion and advertising
Continues……...
WHO - EDM
28 PAR Seminar, 3 October 2002

Key elements of drug regulatory system
….continued
Basic functions in drug regulation (2)


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Inspection of manufacturing and distribution channel premises
Adverse drug reaction monitoring
Authorization of clinical trials
Monitoring of drug dispensing and prescribing practices
Monitoring of drug utilization and promotion of rational drug use
Application of sanctions
WHO - EDM
29 PAR Seminar, 3 October 2002

Drug regulation is a multi- faceted activity at the centre of complex interactions
Government
Experts
Manufacturers
Products
Regulatory authority
Prescribers
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
WHO - EDM
30 PAR Seminar, 3 October 2002

Drug regulation is a multi- faceted activity at the centre of complex interactions
Government
Experts
Manufacturers
Products
Regulatory authority
Prescribers
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
WHO - EDM
31 PAR Seminar, 3 October 2002

Drug regulation is a multi- faceted activity at the centre of complex interactions
Government
Experts
Manufacturers
Products
Regulatory authority
Prescribers
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
WHO - EDM
32 PAR Seminar, 3 October 2002

Drug regulation is a multi- faceted activity at the centre of complex interactions
Government
Experts
Manufacturers
Products
Regulatory authority
Prescribers
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
WHO - EDM
33 PAR Seminar, 3 October 2002

Drug regulation is a multi- faceted activity at the centre of complex interactions
Government
Experts
Manufacturers
Products
Regulatory authority
Prescribers
Medicines
Patients/Consumers
Importers/Wholesalers/Retailers
WHO - EDM
34 PAR Seminar, 3 October 2002

The challenges:
 the health system counts on DRA for good, safe, and effective medicines and for fair rules and control on drug trade, information, and use
 any strategy to improve anything in the pharmaceutcal area involves DRA
 any problem encountered in the pharmaceutical area has something to do with the DRA
WHO - EDM
35 PAR Seminar, 3 October 2002

5.
6.
7.
8.
9.
1.
2.
3.
4.
Country strategies for achieving effective drug regulation
Assess drug regulation performance
Identify and develop priority functions
Provide clear mission and purpose
Create a supportive environment
Formulate adequate legislation
Create appropriate organisational structure
Allocate adequate human and financial resources
Minimise corruption and conflict of interest
Apply appropriate regulatory & enforcement strategies
WHO - EDM
36 PAR Seminar, 3 October 2002

Effective regulation depends on the environment
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 adequate consideration is given to the public health value of drugs drug regulation is not fragmented
DRA is also accountable to the public drug regulation processes are transparent appropriate sanctions are regularly applied strong, organised public interest groups are incentived to support drug regulatory activities there is freedom of association and information
WHO - EDM
37 PAR Seminar, 3 October 2002

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• Political will and commitment:
 clear, firm, and equitable legislation addressing all the relevant issues and carries appropriate sanctions;
 financial and other resources that are commensurate with the designated functions;
 willingness to defend decisions and policies which are to the benefit of public health;
 support when legislated sanctions are imposed for violations of legislation.
38 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• Accountability :
 means being required to account for one’s conduct and actions, usually to an individual or group but ultimately to the public;
 field of medicines is highly commercialized, it is characterized by extreme pressures on the DRA and by intensive lobbying from stakeholders at many levels;
 a system of accountability is essential in managing these tensions.
39 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• Mechanisms to ensure accountability:
 requirement to provide public reports;
 publication of decisions, processes and policies;
 mechanism for appeals against DRA decisions;
 code of conduct for DRA staff and procedure for complaints about actions of DRA and conduct of individual staff;
 formalized mechanisms for consulting experts;
 web site with information about the DRA
40 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• Staff skills:
 evaluators should be qualified in pharmacy, clinical pharmacology, medicine or a similar discipline;
 external expertise should also be available, but authority’s own staff must be capable of understanding and implementing expert advisory body’s recommendations;
 DRA needs staff to investigate breaches of legislation and initiate action in the courts;
 a suitable number of competent administrative staff and computer specialists.
41 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• Staff number:
Number of staff depends on responsibilities to be undertaken.
Major determinants of staff numbers:
 degree to which DRA is prepared to rely on decisions made, and reports prepared, by DRA in other countries;
 presence of local pharmaceutical industry;
 number of products to be processed.
42 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• Staff training:
 Routine training for new staff;
 Scientific skills must be continuously updated to keep pace with drug discovery and development;
 It is therefore essential for suitable training and practical experience to be offered regularly to the staff concerned.
43 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• Premises:
 Data submitted by applicants should be stored with sufficient security to give the applicants the confidence that they cannot be subject to theft or unauthorized copying.
 Professional staff whose responsibilities include sustained periods of concentration will perform more efficiently (in terms of output and reliability) in quiet surroundings.
44 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Computerized system:
• progress of assessment of applications;
• premises for which an inspection is due;
• date of latest approved product information;
• previous decisions taken on same or similar active ingredient & guidance for assessment;
• list of marketing authorizations due to expire;
• regular reports and lists;
• automation of administrative tasks;
• alerts for deadlines.
45 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Access to the Internet:
• information from web sites of other DRAs;
• access to technical literature;
• up-to-date safety information;
• access to web sites of professional associations and NGOs.
Own web site:
• information on decisions;
• regulatory information;
• safety information and alerts;
• open channel for receiving input from society.
46 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Expert advice:
• local expertise from universities, research institutes, and health care facilities (all levels);
• individuals whose advice is seen by community, health workers and government as authoritative and credible;
• fixed-term assignments to reduce risk of dependence on political considerations;
• set broad technical policies so that only difficult applications need to be referred;
• declaration of “no conflict of interest” before and during activities of the expert advisory body;
• reimbursement travel and accommodation plus reasonable remuneration not related to outcome of evaluation.
47 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Fees and cost recovery:
• for all applications and unrelated to outcome;
• certifications & annual fees (support PM activities);
• high enough to contribute significantly to effective functioning of DRA without affecting drug price;
• conducting services for profit is contrary to purpose and ethic of and distracts from regulatory work;
• fees relate to amount of work (fees for generics are lower because they require less assessment work);
• low or no fees for vital drugs with limited market, annual fee can be based on annual sales;
• fee structure should be transparent.
48 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Special access schemes:
• allow access to unregistered drug products in special or emergency situations;
• avoid de facto marketing.
49 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Transparency (1):
DRA must answer to both government and the public on:
 how it fulfils its mission to protect public health;
 how it prevents corruption;
 how it prevents decisions unfair to those regulated.
50 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Transparency (2):
• printed and published policies and procedures;
• give reasons for decisions;
• transparency is the most efficient way to work:
no time spent clarifying policies and attitudes;
terminology is defined so that the parties use the same terms to mean the same thing;
risk of arbitrary decisions is reduced;
DRA’s image is ‘they implement rules’ rather than ‘they decide’;
‘competence’ vs ‘bureaucracy’.
WHO - EDM
51 PAR Seminar, 3 October 2002

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Written policies:
• decisions on individual applications become easier;
• examples:
when data on bioequivalence are required;
when evaluation reports prepared by another
DRA will be accepted;
which fixed-dose combinations are considered rational;
when and from which countries certificates are accepted;
what are the acceptable reference sources for drug information.
WHO - EDM
52 PAR Seminar, 3 October 2002

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Written procedures:
• staff understand their own role;
• assessment deadlines are predictable;
• lines of communication are clear;
• documentation and reasons for decisions accessible and are easy to identify;
• SOP: written procedure giving instructions for performing operations (e.g., reception of applications, individual steps of assessment, issuance of marketing authorization, equipment operation, validation of analytical methods)
53 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Example of part of SOP on WHO-type certificate:
Decision tree for WHO-type certificate
Obtain WHO-type
Certificate
Issueing authority is in list of reference countries?
Yes
No
Does product have MA in exporting country?
Yes
No
Check if product is exactly the same
Review product information and adapt if necessary
Review bioequivalence if required
Review stability data if required
Check if analytical methods are applicable in QC lab
Proceed as if no certificate was submitted
54 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Quality system:
• infrastructure, encompassing organizational structure, procedures, processes, and resources;
• organized set of actions necessary to ensure that patients, applicants, and regulators are satisfied that assessment and decisions are within legal requirements and guidance, and consistent with protection and promotion of public health.
55 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Quality manual:
• contains defined and documented DRA’s policies and objectives;
• DRA must ensure that policies are understood and implemented at all levels in the DRA;
• describe legal status of all elements of DRA (drug registration, inspectorate, QC lab, etc.);
• code of ethics and conduct relating to all DRA activities;
• names, qualifications, and terms of reference of the senior staff and other DRA personnel, both internal and external; ……………
56 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Quality manual (continued):
• training strategies and arrangements for all DRA staff;
• organization chart showing lines of authority, responsibility and allocation of functions;
• documented procedures for issue, suspension and revocation of marketing authorizations;
• list of subcontractors used for specific DRA work and details of the documented procedures for assessing and monitoring their competence;
• details of appeals procedures; ………….
57 PAR Seminar, 3 October 2002
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
Quality manual (continued):
• procedure for ensuring that complaints are investigated and shortcomings revealed;
• list of staff members responsible for investigating complaints and those with authority to take remedial action;
• system of records which demonstrates compliance with obligations under national legislation and demonstrates that the quality system is operating satisfactorily.
58 PAR Seminar, 3 October 2002
WHO - EDM

59 PAR Seminar, 3 October 2002
The EMEA Quality Manual/Documentation System Structure
EMEA Mission Statement &
Quality Policy
EMEA Policies
EMEA Core & Key Tasks
(Process
Maps/Flowcharts)
EMEA SOPs
EMEA Forms
Standard Documents
Templates
WHO - EDM

60 PAR Seminar, 3 October 2002
The EMEA Quality Manual/Documentation System Structure
EMEA Forms
Standard Documents
Templates
EMEA SOPs
EMEA Core & Key Tasks
(Process
Maps/Flowcharts)
EMEA Policies
EMEA Mission Statement &
Quality Policy
WHO - EDM

PROVISIONS AND PREREQUISITES FOR
REGULATORY CONTROL
• A regulatory “culture” :
 DRA should lead its staff to independent thinking, impartiality and pride in their work.
 Everyone should be motivated by a desire to ensure that effective, safe and good-quality drug products are available to the public in adequate quantities and are used rationally.
 It should be stressed that staff who succumb to favours from outside sources are damaging the reputation of the whole organization, including that of their colleagues.
61 PAR Seminar, 3 October 2002
WHO - EDM

Drug legislation and regulation
Rationale for state role
Key elements of drug legislation
Key elements of drug regulatory system
Drug regulation and public health
62 PAR Seminar, 3 October 2002
WHO - EDM

World Health Assembly resolution 52.19
24 May 1999: WHO’s Revised Drug
Strategy
URGES Member States:
(1) to reaffirm their commitment to …… taking all necessary concrete measures in order to ensure equitable access to essential drugs;
(2) to ensure that public health interests are paramount in pharmaceutical and health policies;
(3) to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs;
WHO - EDM
63 PAR Seminar, 3 October 2002

World Health Assembly resolution 52.19 24
May 1999: WHO’s Revised Drug Strategy
Implications for drug regulatory authorities:
- put public health as first priority of regulatory system development strategy and decisions
- contribute to develop market of good quality, safe, effective,and affordable drugs
- improve drug assessment and market control
Improve regulatory system's capacity to meet needs of health professionals and public
WHO - EDM
64 PAR Seminar, 3 October 2002

Access to quality drugs:
WHO - EDM
65 PAR Seminar, 3 October 2002

Drug regulation and public health
 Mission and objectives clearly stated
 Possibility to assess attainment of objectives
 Procedures and outcomes transparent to applicants, health professionals, and public
 Arguments used to reach decision accessible to the public
 Reasonable duration of assessment without compromising quality, safety & efficacy
9th ICDRA 29/4/1999
WHO - EDM
66 PAR Seminar, 3 October 2002

Drug regulation and public health
 Expedite review for orphan and outstanding public-health-value drugs
 Accountability to government, those regulated, and the public
 Personnel adequately trained, highly qualified, of high integrity
 Human resource development programme
9th ICDRA 29/4/1999
67 PAR Seminar, 3 October 2002
WHO - EDM

Drug regulation and public health
 Mechanisms for appeal and for citizens' complaints
 Access to appropriate knowledge and technology
 Citizens are provided with accurate and appropriate drug information
 Mechanisms to ensure quality of operating procedures
9th ICDRA 29/4/1999
68 PAR Seminar, 3 October 2002
WHO - EDM

Drug regulation and public health
WHO - EDM
69 PAR Seminar, 3 October 2002

TECHNICAL COMPLEXITY OF
REQUIREMENTS
ICH
70 PAR Seminar, 3 October 2002
LDC
IC
WHO - EDM

WHO - EDM
71 PAR Seminar, 3 October 2002

WHO - EDM
72 PAR Seminar, 3 October 2002

..approach to drug regulation must be attuned to available resources...
...problems in establishing drug control have too often resulted from the adaptation of provisions successful elsewhere but of a complexity that precludes their effective implementation in the country of adoption...
WHO Expert Committee on Specifications for Pharmaceutical Preparations, TSR 790, 1990
WHO - EDM
73 PAR Seminar, 3 October 2002

Drug regulation and public health
Setting priorities based on available resources:
 ensure effective market control:
 establish list of authorized/marketed products,
 strengthen inspection of distribution channels (if appropriate limit number of entry points for imported drugs and number of distributors),
 establish adequate sanctions for violators;
 establish GMP requirement and inspections;
 identify ‘reference’ DRAs for reports, decisions, drug information, safety alerts;
 focus on regulation and control of generics;
 build collaboration with academic and research intitutions and NGOs to address drug selection and rational use.
74 PAR Seminar, 3 October 2002
WHO - EDM

Huge differences in regulatory environment do exist.
What can regulators do?
 Wait for political will, improved legislation, more resources to appear ?
 Or rather try to improve regulatory work with current environment and resources in order to maximise its potential for improving public health?
WHO - EDM
75 PAR Seminar, 3 October 2002