Drug regulation is a complex task, with many stakeholders and vested interests involved. For this reason there are a number of basic requirements.

Sound legal basis, adequate human and financial resources

A DRA can be effective only if it has a legal basis for all its functions. It must have: sufficient competent administrative and technical staff with the necessary integrity; adequate and sustainable funding; access to external experts and international contacts; access to a quality control laboratory; and a reliable system of law enforcement in the courts. The national drug policy must address all of these factors.

Independence

To maintain public confidence the DRA must operate, and be seen to operate, in an independent, authoritative and impartial manner. It must be funded by the government or by fees collected from industry and clients. However, in the latter case, the DRA must be careful that decisions to grant product registration and licences for establishments are not biased by the need to collect fees from pharmaceutical companies and other clients. Fees levied by the DRA should not be so high that they discourage applications for the registration of essential drugs, and act as a barrier to drug availability and affordability. Provisions should therefore be in place for a reduction of or exemption from registration fees in order to ensure that vital and life-saving drugs are available.

It is also important that drug regulatory functions are separated from drug supply functions and from agencies involved in supply management, in order to maintain independence and ensure that there is no conflict of interest. In some situations the DRA can authorize an independent body to perform functions such as drug evaluation and inspection of manufacturers, to ensure that they comply with GMP.

One important policy decision is where to site the DRA: whether it should be within the ministry of health, or within a technically and managerially independent organization that reports to the minister or should be totally independent. Some of the key policy issues concerning the DRA’s independence are presented in Table 3. This shows that an organization (which may include the drug quality control laboratory as well), which is technically and managerially independent but reports directly to the minister of health, can have the advantages of a fully independent agency without most of its disadvantages.

Table 3. Key policy issues on the independence of a drug regulatory agency

Transparency

One of the keys to an honest and accountable DRA is transparency in all its procedures and outcomes for all stakeholders. Transparency and openness help to prevent bias and corruption. Some of the means of achieving transparency in drug regulation are:

• definition, publication and dissemination of the requirements for information to be submitted to the DRA in support of various types of applications;

• publication of the criteria that the DRA uses and the procedures it follows when making decisions about applications;

• publication of the DRA’s decisions (regular comprehensive lists of drugs registered, renewals and withdrawals) and of the information upon which these are based; a DRA web site may be a convenient way to achieve this.