Regulatory authorities Administration

Recognizing these problems, UK food regulatory authorities have generally abandoned the use of quantitative microbial counts as enforceable standards of food quality. Despite this, the European Pharmacopoeia has introduced both quantitative and qualitative mierobial standards for non-sterile medicines, which might become enforceable in some member states. It prescribes varying maximum total microbial levels and exclusions of particular species according the routes of administration. The British Pharmacopoeia has now ineluded these tests, but suggest they should be used... 

The Australian TGA is by far the largest in terms of the number of staff Venezuela and the Netherlands rank second and third, respectively. Cypms has the smallest number of registration staff—two pharmacists and three administrative staff—who are also responsible for licensing and GMP inspection. Of all the dmg regulatory authorities, only those of Australia, Cypms and Tunisia have more administrative staff than professional staff The dmg regulatory authorities of Estonia, Uganda and Zimbabwe do not employ administrative staff for the registration unit, and it is not clear whether administrative matters are handled by the professionals. 

Figure 8.5 shows the number of applications per staff member (professional plus administrative staff) and the number of applications per professional staff member. The workload per person related to registration varies greatly among the dmg regulatory authorities. Cypms has the largest load per individual professional staff member, and ranks second in workload per staff member of any grade. 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

Some regulatory authorities have foreseen the future impact of TM and set up appropriate guidelines. The European Union has legislation for traditional herbal products. Another example is the Therapeutic Goods Administration of Australia, which has set up a complementary medicine section that controls the regulatory practices for TM. 

Once a decision has been made to develop a compound further following the extensive pre-clinical pharmacological and toxicological studies, approval for the first clinical studies must be sought from the regulatory authority (Medicines Board in Europe or the Food and Drug Administration in the USA). A clinical trial of a new drug is, in the words of Bradford Hill (in his Principles of Medical Statistics) ... 

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. 

The application for a clinical trial authorisation (CTA) for the first administration of a NME to man comprises the same elements as all other CTAs but, of course, there will be no clinical data. The regulatory authority known as the competent authority (CA) of the EU member state requires receipt of confirmation of the EU clinical trials database (EUDRACT) number, a covering letter, a completed application form, the protocol with all current amendments, the IB and a full Investigational Medicinal Product Dossier (IMPD) (see below). If the study is to be conducted in more than one member state, a list of CAs should be included. If the opinion of the lEC is available, it should be provided. 

Module 1 Administrative information and prescribing information. This contains documents specific to each region including (e.g. application forms or the proposed label for use in the region) the content and format of this module will be specified by the relevant regulatory authorities. 

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