It is widely accepted nowadays that any drug that has the potential to do significant good may also have the potential to do significant harm. This realisation arose only with the advent of the powerful modern drugs that we now take for granted. Before the antibiotic era, there were very few really powerful drugs, apart from anaesthetics and opiate analgesics. The drug regulations and controls that existed were intended primarily to ensure the good quality of the product, just like the controls governing other types of marketed products. Then, in the 1960s, the thalidomide tragedy made us all aware of the terrible and unexpected effects drugs might have, in addition to their intended beneficial actions. In those parts of the world where most pharmaceutical discovery was concentrated - the US, Western Europe and Japan - different sets of regulations were drawn up by health ministries in an attempt to build a firewall against the possibility of another thalidomide tragedy. Because each country's regulatory authority went its own way in this endeavour, the result was a plethora of regulations which made it increasingly time-consuming and costly for manufacturers to register their products in developed countries. The situation in Third World and developing countries was still largely unregulated, and these countries often served as test-beds for new drugs, to provide the clinical evidence of efficacy and safety in large-scale studies which then enabled their manufacturers to obtain marketing authorisations in the developed world.

During the 1980s and 1990s, many of these developing countries have been achieving increasing levels of prosperity, leading, inter alia, to improvements in healthcare. As a result they have developed a new awareness of the need to ensure that drugs used by their people are safe and effective. This has, in fact, become an important element in their national pride and their perception of themselves as fully fledged members of the world community of nations.

The response to the newly-felt need for a pharmaceutical regulatory system has differed from one country to another. In those which were, until fairly recently, British colonies, there was the British example to draw on; this underpins much of the regulatory framework in Singapore and Malaysia, for example. Other countries, particularly those in Central and Eastern Europe (CEE), had a long-standing medical tradition and were hindered in the development of pharmaceutical regulation for some decades of communist rule; once freed from that, they set about catching up with their Western neighbours. This is, essentially, the process that has been transforming the regulatory environment in Poland, Hungary and the Czech Republic.

There are, however, many countries without a strongly-established tradition of medicine and pharmacy, and lacking also a regulatory system inherited from a colonial power. This is true of several countries in Latin America and the Far East, which have had to construct their own regulatory frameworks from the beginning.

So the pharmaceutical regulatory systems of developing countries are reminiscent of a patchwork quilt, with diversity rather than harmony as its most distinguishing characteristic. One may, however, identify some common factors. One is that few developing countries envisage that there will be a flow of home-grown novel pharmaceutical products; realistically, they know that these drugs will be discovered and first licensed in countries of the developed world. So their regulatory screening is based on this assumption, and many developing countries demand, as part of the application for product registration, that the applicant produces a free sale certificate (FSC) from the country of origin. Some go farther and insist on two or more such certificates, with at least one coming from a short-list of countries where regulatory standards are known to be stringent.

Unfortunately, provision of a FSC does not, usually, absolve the applicant from having to produce a full product dossier, and some countries even insist on local clinical trials to establish the safety, efficacy and appropriate dosage of the new drug in their own populations.

Another source of diversity is the area of intellectual property (IP) protection. Although most countries have signed up, or will shortly sign up, to the General Agreement on Tariffs and Trade-Trade Related Intellectual Property Rights (GATT-TRIPS) agreements regarding patent provisions for pharmaceuticals, those which have come to this recently are not obliged to observe the rules fully until 2005. Some of these countries still have what Western pharmaceutical companies would regard as a cavalier attitude to patent exclusivity. Indeed, in some developing countries there is no legal protection for the confidentiality of the material in an application dossier, and there is a real risk that it will be leaked to some local manufacturer who will then produce a copy of the product. This is admittedly a temporary problem which should be resolved in most countries after 2005, but in the meantime it is causing major problems for the multinational pharmaceutical companies.

If GATT-TRIPS is a process which imposes some degree of harmony in the IP area, there are moves afoot also to bring harmonisation into the broader regulatory field. The most advanced of these is the European Union (EU) system, now compulsory, which provides unified regulatory approval systems for novel drugs and products of biotechnology on the one hand, and conventional, non-novel drugs on the other. These are the centralised and decentralised (or mutual recognition) systems, and it might be thought that the latter would be an ideal model for groups of countries such as those in Association of South East Asian Nations (ASEAN) to adopt. This turns out, however, to be a rather simplistic notion; it takes no account of the fact that these groupings of developing nations are not bound together by a legal framework, as is the EU. Perhaps more crucially, there are sensitive concepts of national identity and cultural amour-propre to be reckoned with, as well as the fact that some of the nations which forged the EU were once major colonial powers, some of which ruled and exploited the developing countries now struggling to establish their own pharmaceutical regulatory systems.

A more promising model for imitation is the International Conference on Harmonisation (ICH) process, originally conceived as a way in which the US, Europe and Japan could achieve harmony in the guidelines which they offer to applicants for marketing authorisations. A unified guideline on, for example, the conduct of clinical trials would mean that studies carried out to satisfy Japanese regulators would also satisfy those in Europe and the US.

In fact, ICH has largely achieved the objective of developing harmonised guidelines covering all important aspects of the quality, safety and efficacy testing of pharmaceutical products. It is now turning its attention to something even more ambitious - a common technical document, or product dossier, which will be acceptable in all participating countries. This means that an applicant would have to compile just one package of support material to satisfy the regulatory authorities in the US, Japan and all the countries of the EU.

It is perhaps too much to hope that developing countries will want to instantly fall into line and accept the same dossier format, but the ICH process is turning its attention outside the original founding countries, and in one area of the world at least - the ASEAN countries- the view is being expressed by some regulators that the ICH model might make a good basis for a harmonised system for them. It is estimated that such a harmonised regulatory system in ASEAN might take 10 years to achieve.

This report selects some of the major developing countries and provides a summary of their regulatory systems. The selection is made partly on the basis of market size, and partly on the presence of a reasonably advanced regulatory system; for example, in South East Asia, Laos has been omitted because its regulatory system is still in an evolutionary state, and the same applies to some of the CIS countries.

The International Federation of Pharmaceutical Manufacturers' Associations (IFPMA) Compendium (1994) on Regulation of Pharmaceuticals for Human Use has been an invaluable source of information for the report. The author wishes to express his gratitude to IFPMA for the use of material in this report. Pharmaceutical Regulations in Emerging Markets.

Emerging markets in Central and Eastern Europe, Asia, Latin America and South Africa offer a wide range of opportunities for the pharmaceutical industry. Unfortunately, the regulatory environments within these developing countries are varied and complex. Individual nations are at different stages, changing their regulatory systems to EU, US or Japanese standards.

Scrip Reports provides you with a clear, concise overview of these complicated regulations. It will enable you to evaluate which developing countries are ripe for pharmaceutical expansion and understand the essentials of each market's regulatory environment.

This report covers the regulations in the following countries: Argentina, Brazil, China, Czech Republic, Estonia, Hong Kong, Hungary, India, Indonesia, Lithuania, Malaysia, Mexico, Pakistan, Poland, Russia, Singapore and Thailand.

PUBLISHED: JUNE 1998
REF: BS960E
PAGES: 150+
PRICE: £520/$1,095/¥125,000

CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY
ABBREVIATIONS

CHAPTER 1 DEVELOPMENT OF REGULATORY SYSTEMS FOR PHARMACEUTICAL PRODUCTS
1.1 Historical review
1.2 Benchmarks: current regulatory systems in the developed world
1.3 Product safety: an overriding concern
1.4 Measurements of efficacy
1.5 Establishing and monitoring product quality

CHAPTER 2 EASTERN EUROPE
2.1 Market overview
2.2 Poland
2.2.1 The pharmaceutical environment
2.2.1.1 Intellectual property
2.2.1.2 Healthcare
2.2.2 Product registration procedures
2.2.2.1 Regulatory authority
2.2.2.2 Products covered
2.2.2.3 Procedure
2.2.3 Clinical trials
2.2.4 Other regulatory aspects
2.2.4.1 Manufacturing controls
2.2.4.2 Printed packaging materials
2.2.4.3 Pharmacovigilance
2.3 Czech Republic
2.3.1 The pharmaceutical environment
2.3.2 Product registration procedures
2.3.2.1 Regulatory authority
2.3.2.2 Products covered
2.3.2.3 Process
2.3.3 Clinical trials
2.3.4 Other regulatory aspects
2.3.4.1 Manufacturing controls
2.3.4.2 Printed packaging materials
2.3.4.3 Pharmacovigilance
2.4 Hungary
2.4.1 The pharmaceutical environment
2.4.2 Product registration procedures
2.4.2.1 Regulatory authority
2.4.2.2 Products covered
2.4.2.3 Process
2.4.3 Clinical trials
2.4.4 Other regulatory aspects
2.4.4.1 Manufacturing controls
2.4.4.2 Printed packaging materials
2.4.4.3 Pharmacovigilance
2.5 Slovakia
2.5.1 Product registration procedures
2.5.1.1 Regulatory authority
2.5.1.2 Products covered
2.5.1.3 Process
2.5.2 Clinical trials
2.5.3 Other regulatory aspects
2.5.3.1 Manufacturing controls
2.5.3.2 Printed packaging materials
2.5.3.3 Pharmacovigilance
2.6 Estonia
2.6.1 The pharmaceutical environment
2.6.2 Product registration procedures
2.6.2.1 Regulatory authority
2.6.2.2 Products covered
2.6.2.3 Process
2.6.3 Clinical trials
2.6.4 Other regulatory aspects
2.6.4.1 Manufacturing controls
2.6.4.2 Printed packaging materials
2.6.4.3 Pharmacovigilance
2.7 Lithuania
2.7.1 The pharmaceutical environment
2.7.2 Product registration procedures
2.7.2.1 Regulatory authority
2.7.2.2 Products covered
2.7.2.3 Process
2.8 Russia
2.8.1 The pharmaceutical environment
2.8.2 Product registration procedures
2.8.2.1 Regulatory authority
2.8.2.2 Products covered
2.8.2.3 Process
2.8.3 Clinical trials
2.8.4 Other regulatory aspects
2.8.4.1 Manufacturing controls
2.8.4.2 Printed packaging materials
2.8.4.3 Pharmacovigilance

CHAPTER 3 SOUTH EAST ASIA
3.1 Market environment
3.2 Indonesia
3.2.1 The pharmaceutical environment
3.2.2 Product registration procedures
3.2.2.1 Regulatory authority
3.2.2.2 Products covered
3.2.2.3 Process
3.2.3 Clinical trials
3.2.4 Other regulatory aspects
3.2.4.1 Manufacturing controls
3.2.4.2 Printed packaging materials
3.2.4.3 Pharmacovigilance
3.3 Malaysia
3.3.1 The pharmaceutical environment
3.3.2 Product registration procedures
3.3.2.1 Regulatory authority
3.3.2.2 Products covered
3.3.2.3 Process
3.3.3 Clinical trials
3.3.4 Other regulatory aspects
3.3.4.1 Manufacturing controls
3.3.4.2 Printed packaging materials
3.3.4.3 Pharmacovigilance
3.4 Singapore
3.4.1 The pharmaceutical environment
3.4.2 Product registration procedures
3.4.2.1 Regulatory authority
3.4.2.2 Products covered
3.4.2.3 Process
3.4.3 Clinical trials
3.4.4 Other regulatory aspects
3.4.4.1 Manufacturing controls
3.4.4.2 Printed packaging materials
3.4.4.3 Pharmacovigilance
3.5 Thailand
3.5.1 The pharmaceutical environment
3.5.2 Product registration procedures
3.5.2.1 Regulatory authority
3.5.2.2 Products covered
3.5.2.3 Process
3.5.3 Clinical trials
3.5.4 Other regulatory aspects
3.5.4.1 Manufacturing controls
3.5.4.2 Printed packaging materials
3.5.4.3 Pharmacovigilance

CHAPTER 4 INDIA AND PAKISTAN
4.1 India
4.1.1 The pharmaceutical environment
4.1.2 Regulatory aspects
4.1.2.1 Regulatory authority
4.1.2.2 Products covered
4.1.2.3 Process
4.1.3 Clinical trials
4.1.4 Other regulatory aspects
4.1.4.1 Manufacturing controls
4.1.4.2 Printed packaging materials
4.1.4.3 Pharmacovigilance
4.2 Pakistan
4.2.1 Product registration procedures
4.2.1.1 Regulatory authority
4.2.1.2 Products covered
4.2.1.3 Process
4.2.2 Clinical trials
4.2.3 Other regulatory aspects
4.2.3.1 Manufacturing controls
4.2.3.2 Printed packaging materials
4.2.3.3 Pharmacovigilance

CHAPTER 5 NORTH EAST ASIA
5.1 China
5.1.1 The pharmaceutical environment
5.1.2 Product registration procedures
5.1.2.1 Regulatory authority
5.1.2.2 Products covered
5.1.2.3 Process
5.1.3 Clinical trials
5.1.4 Application procedures
5.1.4.1 Application for manufacturing approval
5.1.5 Other regulatory aspects
5.1.5.1 Manufacturing controls
5.1.5.2 Printed packaging materials
5.1.5.3 Pharmacovigilance
5.2 Hong Kong
5.2.1 The pharmaceutical environment
5.2.2 Product registration procedures
5.2.2.1 Regulatory authority
5.2.2.2 Products covered
5.2.2.3 Process
5.2.3 Clinical trials
5.2.4 Other regulatory aspects
5.2.4.1 Manufacturing controls
5.2.4.2 Printed packaging materials
5.2.4.3 Pharmacovigilance
5.3 Korea
5.3.1 The pharmaceutical environment
5.3.2 Product registration procedures
5.3.2.1 Regulatory authority
5.3.2.2 Products covered
5.3.2.3 Process
5.3.3 Clinical trials
5.3.4 Other regulatory aspects
5.3.4.1 Manufacturing controls
5.3.4.2 Printed packaging materials
5.3.4.3 Pharmacovigilance
5.4 Taiwan
5.4.1 The pharmaceutical environment
5.4.2 Product registration procedures
5.4.2.1 Regulatory authority
5.4.2.2 Products covered
5.4.2.3 Process 5.4.3 Clinical trials
5.4.4 Other regulatory aspects
5.4.4.1 Manufacturing controls
5.4.4.2 Printed packaging materials
5.4.4.3 Pharmacovigilance

CHAPTER 6 LATIN AMERICA
6.1 The pharmaceutical market
6.2 Argentina
6.2.1 The pharmaceutical environment
6.2.2 Product registration procedures
6.2.2.1 Regulatory authority
6.2.2.2 Products covered
6.2.2.3 Process
6.2.3 Clinical trials
6.2.4 Other regulatory aspects
6.2.4.1 Manufacturing controls
6.2.4.2 Printed packaging materials
6.2.4.3 Pharmacovigilance
6.3 Brazil
6.3.1 The pharmaceutical environment
6.3.2 Product registration procedures
6.3.2.1 Regulatory authority
6.3.2.2 Products covered
6.3.2.3 Process
6.3.3 Clinical trials
6.3.4 Other regulatory aspects
6.3.4.1 Manufacturing controls
6.3.4.2 Printed packaging materials
6.3.4.3 Pharmacovigilance
6.4 Mexico
6.4.1 The pharmaceutical environment
6.4.2 Product registration procedures
6.4.2.1 Regulatory authority
6.4.2.2 Products covered
6.4.2.3 Process
6.4.3 Clinical trials
6.4.4 Other regulatory aspects
6.4.4.1 Manufacturing controls
6.4.4.2 Printed packaging materials
6.4.4.3 Pharmacovigilance

CHAPTER 7 SOUTH AFRICA
7.1 Registration procedures
7.1.1 Regulatory authority
7.1.1.1 Products covered
7.1.1.2 Process
7.1.2 Clinical trials
7.1.3 Other regulatory aspects
7.1.3.1 Manufacturing controls
7.1.3.2 Printed packaging materials
7.1.3.3 Pharmacovigilance

CHAPTER 8 THE INTERNATIONAL CONFERENCE ON HARMONISATION
8.1 Background to ICH
8.2 ICH2
8.3 Current status of ICH process
8.4 Regulatory communications
8.5 The future of the ICH process
8.5.1 Common technical document
8.6 Future directions
8.7 Implications of ICH for developing countries

LIST OF TABLES
Table 2.1 Size and growth of Central and Eastern European pharmaceutical markets Table 2.2 Multinational pharmaceutical companies in Estonia, 1997
Table 2.3 Leading Russian pharmaceutical companies
Table 3.1 Pharmaceutical market forecasts for five ASEAN countries
Table 5.1 Data requirements for new drugs, China
Table 6.1 Leading pharmaceutical companies in Argentina, 1996-1997
Table 8.1 Progress on guidelines at ICH2
Table 8.2 Finalised ICH Guidelines

LIST OF FIGURES
Figure 3.1 Division of the Malaysian pharmaceutical market by therapeutic category
Figure 3.2 Procedures for aprocessing a Stage III registration application for pharmaceutical products
Figure 5.1 Organisational structure of the Ministry of Public Health and the Drug Policy and Administration Bureau
Figure 5.2 Stucture of the nationwide drug regulatory system
Figure 6.1 Pharmaceutical markets in Latin America, 1996

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© PJB Publications Ltd. 2001 All rights reserved.