Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Registration Procedures in South Africa

Dr. Silvia Sanner (Abschlußjahr: 2007)

Language: English

Regulation is reality in the South African market.

Over the last 30 years, South Africa has developed a medicines regulatory authority with international recognized standing. The Medicines Control Council (MCC) will play a prominent role in facilitating the harmonisation of drug regulation and control in Southern Africa.

The registration of medicine is governed by the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965 as amended (hereafter the “Act”) and the Regulations and Guidelines published in terms thereof.

Guidelines are constantly evolving as a result of scientific developments and harmonisation of the requirements of regional and international authorities. The aim of these Guidelines is to assist applicants in the preparation of documentation for the registration of medicines for human use. The types of medicine include a new medicine for a new chemical entity (NCE), a multisource (generic) product, a product line extension, and a biological medicine.

The objective of this Master thesis is to examine next to different types of evaluation procedures especially the requirements for the registration of a generic product in terms of the provision of the Act and in order to meet the requirements of quality, safety and efficacy. Major focus has been laid on the definition when bioavailability or bioequivalence data will be required in order to prove safety and efficacy, to examine the design and conduct of studies and the evaluation of data and to examine when in vitro instead of in vivo data may be used.

The preparation and submission of an application encompasses a screening submission and a full submission. The screening process endeavours to confirm that all the data required have been included and does not involve evaluation of either the data or any motivation of omission of data. Applications for registration should be submitted on the Medicines Registration Form (MRF1) and all details including administrative particulars, labelling, foreign registration information and the requirements for pharmaceutical and analytical information should be completed according to the Guideline General Information. The requirements for pharmaceutical and analytical information are divided into ten parts in the application form as described in the Guideline Pharmaceutical and Analytical. To complete the parts mentioned above all aspects described in the Guidelines on Post-Importation Testing, Stability, Biostudies, Dissolution and SA GMP should be considered carefully. It is a legal requirement that data submitted for evaluation should substantiate all claims and should meet technical requirements of quality, safety and efficacy of the product for the purposes for which it is intended. In some instances scientific developments may dictate alternative approaches. When a deviation from a guideline is decided on, a detailed motivation giving the reason(s) for the deviation and justification for the alternative approach should be included in the expert report submitted with the application.

Medicines registered by Council should, during its entire life cycle, comply with the information that has been evaluated and approved by MCC. Regular inspections are performed at the applicant/manufacturer of such medicines in order to ensure compliance with quality control and Manufacturing principles as well as compliance with the registration dossier. The PIC/S decided at their joint committee meeting in Geneva on 15/16 May 2007 that South Africa´s Medicines Control Council has been accepted as a member of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme as from 1 July 2007. South Africa thus becomes the 31st member of a structure that is recognised as defining “stringent” regulatory authorities.

In South Africa, 49% of all volumes sold are generics. The generic substitution provision in the Medicines Act obliges pharmacists to inform the client about a generic equivalent when the doctor has prescribed a more expensive brand name and offer the former to the client. It is a major goal of the National Drug Policy to ensure adequate and reliable supply of safe, cost-effective and affordable drugs of acceptable quality to all citizens of South Africa. The prices of generic medicines are far below the discounts offered by large firms which strongly suggests that generic products must form part of the solution of the health crisis (AIDS) in South Africa. Therefore, it is essential that regulatory approval and manufacturing standards are in place that ensure that generics meet bioequivalence and bioavailability standards. The aim is achieved through strengthening the Medicines Control Council (MCC), rationalising drug registration, controlling registration of practitioners and the licensing or premises, enhancing the inspectorate and laboratory functions, and promoting other quality assurance measures.

For a developing country, South Africa has an advanced and comprehensive regulatory regime. In an environment characterised by resource limitations, it is important to prevent overregulation and to understand the costs and benefits that regulation imposes on various players. This will ensure that the regulation supports long-term development goals. There is, however, currently no legislation compelling regulatory agencies to assess and account for regulation on a cost-benefit basis. This weighs especially heavy in South African environment of high unemployment and modest economic growth.

Regulation without the necessary checks and balances, however, can create as many problems as it provides solutions. Therefore, and in order to promote an efficient and effective regulatory regime the necessity/benefit of an Regulatory Impact Assessment Design should be discussed for South Africa. RIAs can ensure that regulation is well thought through and designed taking into account both the intended and unintended impact.

Pages: 62