Drug Regulation Enabling Environment Assessment Guide

Review the political and socioeconomic conditions to establish whether they support drug regulation.

• Does government policy give priority consideration to the economic rather than social benefits provided by pharmaceutical products?

• Has a freedom of information act been passed?

• Is there freedom of association?

• Does the government recognize the need for accountability?

• Does the government encourage transparency?

• Does the government provide mechanisms for public complaints and oversight including in the area of drug regulation (i.e. mechanisms for provision of an ombudsman)?

Regulatory and Enforcement Strategies Assessment Guide

Regulatory strategies

• Does the agency have a written strategy for implementing drug regulation?

• Does the agency delegate regulatory activities to other public institutions, professional associations or industries?

• Do consumer groups, interested public groups, etc., participate in regulatory affairs? Do they operate on a legal basis? Do they have a code of conduct?

Enforcement strategies

• Which of the following instruments are used to enforce drug regulation?

• Persuasion?
• Punishments?
• Legal sanctions?
• Financial fines?
• Administrative measures such as warning letters?

• Do any social pressures operate? For example, on the part of:

• peers;
• consumers;
• public interest groups.

• Are any of the following strategies used to achieve objectives:

• negative incentives for violation, such as “negative publication” (in which, for example, the name of the offending company, individual or pharmacy is published), or frequent inspection;

• positive incentives for compliance, such as reduction of fees or letter of acknowledgement;

• implementation of voluntary compliance or self-regulation.

Drug Regulation Structure

Analysis of drug legislation and identification of weaknesses

• What is the mission of drug regulation? Is this mission formally written down?

• Is drug legislation comprehensive?

• Are the areas to be regulated defined?

• Are functions, responsibilities and powers of all the relevant parties defined?

• Are drug regulations, norms, standards and procedures adequate?

• Are there provisions for penal sanctions and administrative measures?

• Does the legislation impose on the regulatory authority any duty to provide information to the public?

Analysis of organizational structure and identification of weaknesses

• Is the regulatory government body federal, state or local?

• Is it a quasi-governmental body?

• Does the drug regulation structure provide independence in decision-making?

• Does the structure provide autonomy, both financially and in terms of recruiting staff?

• Is the distribution of responsibilities, duties and powers in accordance with written terms of reference and drug legislation?

• Are structural and functional linkages between various bodies involved in drug regulation clearly defined?

• Do staff have job descriptions?

• Is the private sector involved in drug regulation activities? If so, is there a legal basis for this? Are the relevant parties accountable? Are they required to submit reports?

• Are planning, monitoring, evaluation and reporting mechanisms in place?

• What are the main constraints with regard to organization and structure? What are the reasons for them?

Assessment of human resources availability and quality, and identification of constraints to implementing drug regulation

• Is the number of staff adequate?

• Do staff have the required qualifications and skills to perform their jobs adequately?

• Do staff believe in the objective of drug regulation?

• Are staff motivated to do their work?

• Is there a system for human resources development?

• Are staff salaries comparable to those paid to similarly qualified individuals in the private sector?

• What are the main constraints in terms of human resources availability? What are the reasons for them?

Assessment of financing mechanisms and identification of constraints

• How is drug regulation financed?
• Is there a specific government budget for drug regulation?
• Is financial sustainability a problem?
• Is there legal provision for collection of fees?
• Are fees collected?
• Is the regulatory agency allowed to use them?
• What are the main financial constraints?

Availability of other resources

• Are resources - such as means of transport, laboratory equipment and apparatus - that are essential for regulation activities readily available? Do they function properly? Is there a maintenance system?

• Is an adequate number of rooms available?

Availability, clarity and transparency of procedures and guidelines

• Are all procedures, guidelines and guides used in drug regulation written down?

• Are they published and distributed to all interested parties?

• Are decisions made by the agency published and distributed to all interested parties? Are they sent only on request?

Drug Regulation Processes

Licensing system: critical assessment of operation and record keeping

• Is there a licensing system? Is it operated by the drug regulatory authority?

• Does the system cover both public and private sectors in the drug sector?

• What are the different types of licences issued?

• Who is authorized to issue licences?

• What conditions must be met before a licence is issued?

• What type of qualifications are required for persons practising as pharmacists, or who are manufacturing pharmaceuticals, importing pharmaceuticals, selling pharmaceuticals by wholesale or retailing pharmaceuticals?

• How is the licensing body linked with other agencies involved in drug regulation?

• Is there a fee system for issuing and renewing licences?

• How many different types of licensed drug establishments are there and how many establishments of each type are there?

• Is the list of licensed drug establishments and persons readily available?

Inspection and surveillance: critical assessment and record keeping

• Is there a drug inspectorate?

• Does the inspectorate perform good manufacturing practice (GMP) inspection and inspection of distribution channels?

• How many inspectors in the country can carry out GMP inspection? How many inspectors are available for carrying out inspection of the distribution chain?

• What is the relationship between the inspectorate and other bodies involved in drug regulation?

• Is GMP inspection activity centralized?

• Is inspection of distribution channels decentralized? Does a reporting mechanism operate between the different levels?

• Do GMP inspectors have guidelines and manuals? Do inspectors of distribution channels have guidelines and manuals?

• Are inspectors qualified professionals? Do they undergo special training in order to be able to carry out inspection?

• Is there an external and/or internal audit and review system to examine the performance of inspectors and/or the inspectorate?

• Does the inspectorate carry out any of the following types of inspection:

• Comprehensive/routine inspection?
• Follow-up inspection?
• Inspection in response to complaints?

• How often is routine inspection carried out?

• Is there a fee system for inspection?

• Does the inspectorate collect samples during GMP inspection, from distribution channels, or as part of post-marketing quality monitoring?

• In each of the last five years, what percentage of the samples tested failed? What was the average failure rate?

• What actions were taken against products that failed tests?

• Are there procedures that must be followed when considering appeals against enforcement measures imposed by inspectors?

• Are inspectors rotated to prevent corruption? Do they make their visits in teams?

• Are the results of inspection accessible to interested parties and to the public?

Drug Regulation Processes

Product assessment and registration: critical assessment of operation and record keeping

• Is there an operational product assessment and registration system?

• Is there a formal standard application form?

• Does registration apply to locally produced drugs? Does registration apply to drugs imported by the public sector?

• What information and evidence must be submitted when applying for registration of products containing:

• new active pharmaceutical ingredients?
• generic drugs?
• fast-track drugs? ^a

• Is a WHO-type Certificate of a Pharmaceutical Product used?

• Do staff working in drug registration follow standard operating procedures?

• Are criteria (i.e. reasons for approval or rejection) for drug assessment and registration written down anywhere?

• Are assessment of applications:

• Carried out by internal staff only?
• Carried out by external expert committee(s)?

• Are any of the assessment activities delegated or contracted out to:

• Other public institutions?
• Individual experts?
• Private institutions?

• Who makes the final decision regarding registration of a product?

• For how long is registration valid?

• On average, how long does it take to register:

• A product containing a new active pharmaceutical ingredient?
• A generic product?
• A fast-track product?

• Is there a time limit for processing of an application form by the registration authority?

• Is there an appellate body?

• How many appeals have been made in each of the last five years? How many decisions were reversed as a result of these appeals?

• Is the drug registration process computerized?

• Does the authority issue the list of registered drugs regularly and update it?

• Are any of the following represented in the assessment and registration process:

• drug manufacturers?
• consumer or patient groups?

• Are fees levied for assessment and registration of products?

• How many applications have been received and processed in each of the last five years:

• for new registration?
• for variation?
• for renewal?
• others?

• How many applications and what types of applications have been rejected in each of the last five years?

• Are WHO-type Product Certificates issued for export products? How many such certificates have been issued in each of the last five years?

• What are the main constraints to drug assessment and registration? What are the reasons for them?

Adverse Drug Reaction Monitoring

• Is there an adverse drug reaction (ADR) monitoring system?

• If so, is the system obligatory or voluntary?

• How many ADR reports have been received per year in each of the last five years?

• What happens to the reports received? How and to whom are they distributed locally and/or internationally?

• Are decisions taken on the basis of ADR monitoring?

• How many decisions have been made as a result of ADR monitoring? What kind of decisions were made?

• Are manufacturers and/or importers required to monitor the ADRs of their products?

Clinical Trials

• Does drug legislation require control of clinical trials carried out in the country?
• Who is responsible for controlling clinical trials?
• How many clinical trial applications have been received in each of the last five years?
• Are there guidelines for conducting clinical trials?
• If so, are they consistent with:

• the Helsinki declaration?
• WHO good clinical practice guidelines?

• Does an ethical committee oversee clinical trials?
• Is there a special procedure for approving importation of drugs for clinical trial?

Control of Drug Promotion and Advertising

• If legislation for the control of drug promotion is in force, is it in line with WHO ethical criteria for drug promotion?

• Is drug advertising and promotion controlled?

• Is there legal provision for controlling drug promotion and advertising?

• Are any restrictions specified in the drug law in relation to control of promotion and/or advertising?

• Which body controls advertising/promotion?

• Is prior approval required for promotional and advertising materials?

• Is there a fee for prior approval?

• How is advertising and promotion monitored?

• Is a product information sheet, data sheet or a summary of product characteristics approved at the time of registration?

• Are patient information leaflets and labels subject to approval?

• Are sanctions applied when laws on product information and promotion are violated? More specifically:

• How many violations of drug promotion laws and regulations have been registered in each of the last five years?

• How many legal sanctions have been enforced in each of the last five years?

• How many administrative measures have been taken in each of the last five years?

• Are there any associations of pharmaceutical manufacturers or companies that practise self-regulation?

• Does the drug regulatory authority provide independent drug information to prescribers, dispensers and the public?

• How are the public and prescribers informed about newly registered drugs?

• Is there a mechanism to prevent false medical claims being made in advertisements?

• Do private organizations and consumers groups participate in the control of drug promotion and advertising?

• If so, do they follow a code of conduct?

• Can they impose sanctions?

• What are the main constraints to controlling drug promotion and advertising? What are the reasons for them?

Output Indicators

Licensing

• For each of the last five years, how many pharmaceutical manufacturers (out of the total number of pharmaceutical manufacturers in the country) were licensed?

• For each of the last five years, how many pharmaceutical importers (out of the total number of pharmaceutical importers in the country) were licensed?

• For each of the last five years, how many pharmaceutical wholesalers (out of the total number of pharmaceutical wholesalers in the country) were licensed?

• For each of the last five years, how many drug retail outlets (out of the total number of drug retail outlets) were licensed retail outlets?

GMP inspection

• For each of the last five years, how many routine or planned inspections (out of the total number of routine or planned inspections in the country) were conducted?

• For each of the last five years, how many pharmaceutical manufacturing plants (out of the total number of licensed pharmaceutical manufacturing plants in the country) were inspected?

• For each of the last five years, how many pharmaceutical manufacturing plants (out of the total number of licensed manufacturing plants inspected) were in violation of the regulations?

• For each of the last five years, how many pharmaceutical manufacturing plants (out of the total number of licensed pharmaceutical manufacturing plants in the country) held a GMP certificate?

Inspection of distribution channels

• For each of the last five years, how many distribution channels (out of the total number of licensed distribution channels in the country) were inspected?

• For each of the last five years, how many planned inspections (out of the total number of planned inspections) were undertaken?

• For each of the last five years, how many distribution channels (out of the total number of distribution channels inspected) were in violation of the regulations?

• For each of the last five years, how many samples (out of the planned total number of samples to be collected) were collected?

• For each of the last five years, how many distribution channels (out of the total number of licensed distribution channels in the country) were in violation of the regulations?

• For each of the last five years, how many drug products (out of the total number of drug samples collected) were found to have exceeded their expiry date?

Product assessment and registration

• How many registered products (out of the total number of products that require registration in the country) are there?

• How many registered products (out of the total number of products currently registered in the country (excluding vitamins) have more than three active ingredients?

• How many applications are currently waiting to undergo the assessment and registration process?

Control of promotion and advertising

• For each of the last five years, how many advertisements and promotions (out of the total number of advertisement and promotions monitored) violated drug regulations?

• For each of the last five years, how many labels and inserts (out of the total number of inserts or labels that were monitored) (for countries with a monitoring system) were inconsistent with what was approved during registration?

Quality control

• For each of the last five years, how many samples (out of the total number of samples submitted or collected) were tested?

• For each of the last five years, how many samples (out of the total number of samples tested) failed quality testing?