Background: Drugs have become an essential necessity in public health, people and the government has become willingly to spend more money on the country’s healthcare system to restore health, save lives, preventing disease and epidemics. Drugs should be properly regulated throughout development, production, importation and subsequent distribution to ensure it is prescribed with safe, effective and of good quality standards. The structure of drug regulations today has evolved over time. During the process, the scope of legislative and regulatory power expanded in result of a series of disastrous events related to pharmaceutical products, the adoption of more restrictive legislative were put in place for stronger safeguard to the public. In comparison to Singapore, Taiwan, US and EU where the drug regulatory system is highly structured, flexible and innovative, Hong Kong (HK) has a relatively simple and stubborn drug regulatory system and drug approval is greatly dependent on the approval status of the advance countries. According to the current registration system in HK, a new drug usually takes about 18-24 months to obtain an approval, and this figure is far behind the standard of Singapore in which medicine could be registered in 60 days. It is vital to have speedy approval process with high standards in safety, efficacy and quality on all approved drugs. If drugs are approved in a rush manner, it will lead to serious adverse drug reactions (ADR), or even deaths in consumption of unsafe, and ineffective drugs. On the other hand, slow approval will make patients suffer and increase the mortality rate to due inaccessibility of appropriate medicines to sustain life and combat diseases. With reference to the initiatives and innovative regulatory frameworks in the abovementioned countries, the modification of the local drug regulatory system is strongly recommended. Aim: 1. To examine the regulatory frameworks between Singapore, Taiwan, US and EU which affect the evaluation timeline required for new drugs approval. 2. As the first study to examine the drug regulations in HK, the regulatory barriers for new drugs submission will be explored and whether the regulatory initiatives from the abovementioned countries may result in an improvement in the overall drug regulation system HK. Method: This dissertation is a literature review and it will employ concentration in the drug regulation systems in Singapore, Taiwan, US and EU with varying levels of pharmaceutical regulation capacities. Search engines including Google, MedLine, PubMed (database up to 2012) with key words search of “Department of Health (DoH), Food and Drug Administration (FDA), European Union (EU), Taiwan FDA, Health Sciences Authority, evaluation routes, drug registration requirement, review timeline, Centre for Drug Evaluation, Pharmaceutical Evaluation Reports, risk management systems, pharmacovigilance, drug legislation”. Results: With an in-depth evaluation of the HK’s guideline and supporting document required for new drug submission, it is highly recommended that unnecessary documents at new drug submission (NDA) should be elimination to facilitate the new drugs approval process. The regulatory frameworks between all studied countries vary significantly in which implementation of initiatives (e.g. multiple evaluation routes, in-house evaluation system) from individual country affects the standards of new drugs approval and the evaluation timeline required to grant approvals. Conclusion: The regulatory frameworks in HK shall be revised with reference to numerous initiatives developed in the regulatory systems in Singapore, Taiwan, Us and EU. The possible key regulatory barriers which leads to the delays in new drugs approvals in HK includes duplication of certificates, limited number of Pharmacy and Poison Board meetings, the requirement of endorsement of new drugs approvals at the legislative council , absence of in-house evaluation system which allows full assessment of submission dossier, deficiency of clinical trials with the inclusion of local population, absence of electronic submission, multiple evaluation routes and rigorous post-marketing pharmacovigilance monitoring system. If the Department of Health (DoH) in Hong Kong could scrutinize the current regulatory frameworks with referenced to these countries, it will improve the overall drug regulatory system and reduce drug lag due to unnecessary barriers. / published_or_final_version / Public Health / Master / Master of Public Health

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Veterinary Needs Appraisals have indicated that there is a need for improved supply of veterinary medicinal products to subsistence and emerging farmers in South Africa. No studies have been conducted to describe and assess the adequacy of the current routes and methods of supply of veterinary medicinal products to these farmers. A combination of focus groups, self-administered questionnaires and direct observations was used to collect information for the purpose of describing and understanding the situation regarding the supply of veterinary medicinal products to the farmers of the Madikwe district. A combination of semi-structured interviews, questionnaires and direct observation was used to gather information. The results indicated that the routes and methods of supply of veterinary medicinal products to the farmers of the Madikwe district were inadequate. The annual sales from outlets within the Madikwe district were poor, with a total of 396 units sold over a period of one year, although there were approximately 2000 farmers in the Madikwe district who were potential clients for these outlets. The majority of products sold by these outlets were ectoparasiticides, followed by Tetracycline antibiotics. The outlets within the Madikwe district were unable to supply vaccines, as they did not have adequate facilities for the storage of these thermolabile products. Farmers had to travel an average of 70 km if they wished to purchase veterinary medicinal products from farmers' co-operatives and pharmacies in larger towns outside the Madikwe district. The routes and methods of supply did not ensure correct storage, and safe and effective use of veterinary medicinal products. Several examples of misuse and incorrect storage and handling of veterinary medicinal products were discovered. Inadequate information transfer, inaccessibility of outlets, poor reliability and quality of outlets and poor service were discovered as reasons for the inadequacy of the routes and methods of supply. Wider distribution of veterinary medicinal products is required but a higher level of control is needed to ensure that products of an acceptable quality are sold. Information and advice must be disseminated together with products. / Dissertation (MMedVet (Pharmacology))--University of Pretoria, 2001. / Paraclinical Sciences / unrestricted

This study identifies and analyzes factors which determine productivity in the drug industry. It shares a general concern about recent decline in industrial productivity in the United States with Abernathy, Clark, and Kantrow (1983), who developed a theoretical framework for analyzing the causes of lackluster industrial performance. According to Abernathy, et al. (1983), performance is determined by government fiscal and monetary policy, production capability, socioeconomic environment,(of which regulation is a subset), and corporate management. This study finds that the theoretical framework of Abernathy et al (1983) can be used as a context for analyzing productivity in the drug industry. In a recent case of drug development, socioeconomic and managerial problems caused costly delays in development, hampering the company's capacity to be productive. The study also finds that the strategy for industrial revitalization developed by Abernathy et al. (1983) is applicable to the drug industry. Specifically, corporate management must integrate the development activities of innovation, production, finance, and marketing more efficiently. More efficient integration will help management to consider the impact of one activity on the others, and to identify deficiencies which can delay development. This will help management cut development time and increase profits, which will help revitalize the drug industry. / Master of Science

Introduction: Due to the increase in healthcare costs, generic medicines have been adopted for used in both developed and developing countries. When a generic or ‘multisource interchangeable medicine’ is to be registered, studies that prove that the generic is equivalent to the Innovator Product (IP) are used. The generic medicine is required to prove that it will mirror the IP in terms of safety, quality and efficacy and, in South Africa, the Medicines Control Council (MCC) ensures that generic medicines meet these requirements. Generic medicines may be registered using bioequivalence data obtained from comparison with a domestic reference product (usually the local innovator product) or in certain cases, a foreign reference product (FRP). The bioequivalence data can either be from in vivo or in vitro studies. The MCC guidelines require that for modified release preparations, in vivo bioequivalence studies are done for approval of registration; the exception being if a proportionally higher dose has already been registered. No information is currently given to prescribers and dispensers or to the public about whether a generic product was registered against a foreign or domestic reference product. Aims and Objectives: 1.) To determine the number of generic medicines in a predetermined sample registered using a FRP as comparator and to document the transparency of pharmaceutical companies when approached to disclose information regarding the registration of these products. 2.) To describe and document the use of the Promotion of Access to Information Act (Act 2 of 2000) [PAIA] from the perspective of a ‘layperson’ in the context of medicines’ regulation, in both private and public bodies. Methods: 20 modified release and Biopharmaceutics Classification System (BCS) class IV products were selected from the ‘generics dictionary’ – a commercial publication – and letters were sent to the manufacturers of the products requesting information about the tests done to prove equivalence and whether they were performed against a domestic or foreign reference product. The same information was also requested from the MCC. The requests were all made using the Promotion of Access to Information Act (PAIA). Results: Nine companies were represented by the 20 products chosen. Information was obtained about thirteen products. Ten of these products were registered using FRPs. Four products were registered based only on comparative dissolution studies. Four companies provided the requested information, two companies responded by refusing the requests and three did not respond at all. The MCC refused the request for information even after an internal appeal was lodged. Conclusions: The Promotion of Access to information Act was unsuccessful in obtaining information from the public body, and partly successful in obtaining it from the private bodies. While the title of the Act seems to indicate that the Act can be used to obtain information as such, it only provides for access to specified records. The MCC and the pharmaceutical companies involved in the study were under no obligation to provide the information as the request had not complied with PAIA requirements. The use of FRPs for registration is a reality in the pharmaceutical industry in South Africa. Neither the public nor healthcare professionals who prescribe medicines or who are involved in dispensing generic medicines as substitutes are aware of whether or not a FRP has been used to register a generic. Interchangeability cannot necessarily be guaranteed if the reference product was not proven equivalent to the local innovator product. It is debatable as to whether or not this information would be of any particular benefit to members of the public. Prescribers may choose to write ‘no substitution’ on their prescriptions if they were unconvinced that an FRP is acceptable. This could have consequences for healthcare costs. Dispensers are the most vulnerable in South Africa as they are obliged by law to substitute generic medicines when innovator medicines have been prescribed. Dispensers’ views on the acceptability of the use of FRPs can be seen as irrelevant. In the end, as this study demonstrates, the only option in the present situation is to rely entirely on the MCC’s rigour in assessing applications for registration of generic medicines.

Federal marijuana policy is constantly changing. This research analyzes the political forces behind these changes, emphasizing the policy per se rather than emphasizing the process by which policy-making occurs. The research is based on a policy-making framework that includes the following concepts: perception of the problem, pluralism, incrementalism, and policy cycles. Of major concern is the "problem perception" stage of this cycle, i.e., how perceptions of marijuana have affected policies toward that drug. Other drugs, particularly opiates, are analyzed only to the extent they affect marijuana policy. In the early 1800's drugs were widely used in America, and they were not perceived as a problem. Later, they were perceived as a medical problem. The Harrison Act of 1914 reflected these medical perceptions. But narcotics soon were perceived as a source of crime, and federal narcotics officials, through court procedures, used the Harrison Act to apply criminal sanctions to narcotics users, and to exclude doctors in private practice from treating drugs as a medical problem. In the 1930's marijuana was perceived by federal officials as a narcotic drug, and marijuana consumption was perceived as a criminal phenomenon. Therefore, the Marijuana Tax Act of 1937 was modeled after the Harrison Act of 1914, with penalties for marijuana violations similar to those of narcotics violations. In 1951 and 1956, the Federal Bureau of Narcotics successfully lobbied to increase the criminal sanctions for marijuana violations, despite opposition presented by the Department of Health, Education, and Welfare. In the 1960's new perceptions began to emerge. The 1962 White House Conference called by President Kennedy critically evaluated existing policies toward narcotics and marijuana, and it suggested that drug consumption should be treated as a medical and social problem rather than as a criminal problem. A content analysis of Presidential messages in the 1960's indicates President Kennedy probably viewed drugs as a medical problem, and Presidents Johnson and Nixon viewed drugs as a criminal problem. The 1960's saw changes in perceptions toward drugs that subsequently led to policy changes. The Narcotic Addict Rehabilitation Act of 1966 provided for emphasis on medical treatment rather than criminal sanctions for narcotics users. This act reflects a change in perceptions of marijuana by allowing probation and suspended sentences for marijuana violations, thus drawing a distinction between the consequences of narcotics consumption and marijuana consumption. The Marijuana Tax Act of 1937 was held to be a valid tax act by the Supreme Court, Litigants continued to attack the constitutionality of the act in their attempts to reverse convictions for violations of marijuana laws. Arguments based on freedom of religion, the right to privacy, the Equal Protection Clause, and cruel and unusual punishment were rejected. Timothy Leary's conviction was overturned, based on a self-incrimination argument, but the Court declined to expand this ruling. The Comprehensive Drug Abuse Prevention and Control Act of 1970 includes provisions indicating a change in perceptions toward marijuana. Of particular importance is the provision allowing federal courts to grant probation for certain marijuana offenses, and then to expunge the offender's record of any reference to criminal sanctions for such offenses. Changes in marijuana policy have been incremental, even in recent legislation. Two groups have been responsible for most of the political conflict and policy related to marijuana. These are the Bureau of Narcotics and the Department of Health, Education, and Welfare. Private groups have been vocal but not influential. Litigants have had limited success in courts due to the lack of a united effort.

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In order to market and sell a new pharmaceutical drug in Canada, the Minister of Health requires the initial applicant to submit clinical test results demonstrating that the drug is safe and effective for human use. Subsequent applicants, who typically lack the resources to conduct expensive clinical trials, must refer to and rely upon the initial applicant's data in their applications to market a generic version of the drug. / On June 17, 2006, the federal government of Canada published a proposed data protection regulation, which would provide an initial applicant with eight years of protection for clinical test results submitted in a new drug submission. This protection would lead to an eight year period of market exclusivity for the drug associated with the clinical test data, regardless of whether that drug was protected by a Canadian patent. / In this thesis, the author first describes what data protection is on a practical level, and distinguishes data protection from other forms of intellectual property rights. Next, the author discusses how various jurisdictions choose to protect clinical test data submitted to their health authorities. Canada's international obligations pursuant to the NAFTA and the TRIPS Agreement are also examined. In this regard, the author argues that Canada is under no obligation to provide initial applicants with eight years of data protection. Furthermore, the author argues that exclusive time-limited property rights in clinical test data are difficult to justify from a theoretical perspective. Finally, the author prescribes certain legislative changes to Canada's proposed data protection regulation.