What Are Legal and Regulatory Systems

Harmonization is particularly useful in developing countries where regulatory laws pose infrastructure problems and gaps. Harmonized and simplified requirements for drug registration can ensure that life-saving medicines are available more quickly in poor countries (Ndomondo-Sigonda and Ambali, 2011). Figure 2-2 describes the value of harmonizing pharmaceutical legislation for different stakeholders. Many regional economic communities are actively promoting the harmonisation of their legislation on food and medical devices. WHO, FAO and other international organizations have tools to help regulators assess the effectiveness of their agencies and identify weaknesses in their systems. For example, the World Organisation for Animal Health, known as OIE1, has developed a tool to assess a country`s veterinary services against international standards (OIE, 2010). Phytosanitary Capacity Assessment, a management tool of the International Plant Protection Convention, helps countries identify the strengths and weaknesses of their plant protection systems. Table 2-1 lists additional capacity assessment tools. the WTO has compiled a long list (Standards and Trade Development Facility, 2011). To this end, regulators need to have surveillance data and understand their data sources. They should also have a sufficiently solid understanding of weaknesses in their system to identify data gaps and know what assumptions to make about unknowable data, and when to rely on the private sector for additional information. Crisis early warning systems are valuable tools for making the most of limited surveillance data. Legal frameworks provide the basis for credible elections and the protection of individual political rights.

However, electoral laws and rules are often unclear, contradictory, outdated, unworkable in practice or politically manipulable. IFES supports the development of clear, coherent and accessible legal frameworks for elections, while promoting effective law enforcement and enforcement. • Develop information management systems and promote the sharing of regulatory information As an information security professional, it is very important to understand the role of laws and regulations and how compliance can affect us from a personal and professional perspective. In many cases, the requirements in which we must work to protect our respective organizations, design new systems and applications, decide retention periods for data retention, recommend encryption or tokenization of sensitive data, and a variety of other activities that are part of a security professional are motivated by the need to comply with one or more rules. Some have the weight of the law and others that are industry standards with commercial but not legal implications. The World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) provide good guidance on what a regulatory framework for food and medical devices should include. The following summary of the role of food and medical device safety legislation is taken from the WHO Effective Medicines Regulations: Ensuring Safety, Efficacy and Quality, FAO and WHO. Ensuring food quality and safety: guidelines to strengthen national food control systems. As described in Chapter 1, the United States has been building its regulatory system in fits and starts for more than 100 years, largely influenced by product safety disasters. Developing countries are now struggling to develop systems that ensure the safety of food and medical devices. This chapter describes the characteristic principles that governments should consider when designing regulatory regimes for food and medical devices. A good system must be responsive; It should be able to act in times of crisis and keep pace with technological change.

It should also focus on results and not stifle innovation. The system must be predictable; That is, regulatory decisions should be fair, not arbitrary or capricious. The level of regulatory oversight of a product should be commensurate with the likelihood that the product will cause harm. Finally, the regulatory system should be independent and not overly influenced by politics or money. ———. 1999. Regulation of vaccines: Building on existing drug regulatory authorities. Geneva, Switzerland: WHO Division of Vaccines and Other Biologicals.

• Quality control systems for reliable laboratory testing • a means of determining when regulatory action is required; and WHO prequalification of vaccine manufacturers in China was not readily granted. In March 2011, WHO recognized China`s regulatory system to meet its vaccine production standards. During a 19-month approval period, Chinese regulators worked to develop a plan that followed WHO`s advice on how to strengthen vaccine regulation. A team of experts from different countries assessed China`s regulatory system using WHO indicators. Compliance with international standards has enabled China to request WHO prequalification and deliver vaccines to UN agencies in the coming years (WHO, 2011d). The Association of South-East Asian Nations (ASEAN) is committed to ensuring harmonization in South-East Asia. In 1992, ASEAN Economic Ministers established the Advisory Committee on Standards and Quality with the aim of harmonizing regulations in several sectors, including food and medical devices (Ramesh and WG3 Chairman). ASEAN regulatory harmonization focuses on four areas: quality, efficiency, safety and governance. The committee has established guidelines for many aspects of food and drug regulation, including labelling, pesticide control, and traditional regulatory compliance established by states, states or international governments.

On the other hand, compliance with company policies and procedures implies compliance with the internal requirements established by the company. However, both help promote accountability in the workplace. Fair competition is a cornerstone of the U.S. economy and led to two important laws enacted on both sides in the early 20th century. The oldest antitrust law in the country is the Sherman Act, enacted in 1890 to prohibit the unjust development of anti-competitive monopolies. Its “sister law” is the Clayton Act of 1914, which gives aggrieved parties the ability to sue the infringing party for unfair competitive practices. This legislation prohibits price fixing and conditional selling, which restrict fair competition and make it illegal to control competing companies. At its core, an effective regulatory system for food and medical devices uses science and risk to develop policy. Regulators should participate in international harmonization and value international cooperation. Ethical enforcement is a crucial element of a regulatory system.

A strong regulatory system protects against public health emergencies, but can communicate quickly and accurately with the public in the event of an emergency. At the very least, the regulation of food and medical devices depends on a regulatory system. All stakeholders should be able to communicate with the regulatory authority on product safety rules. • coordination of responsibilities where the regulatory authority includes more than one body; The minimum requirements described in Box 2-3 relate to regulators of the processes they use to legislate and the data they use to enforce them. An open rule-making system ensures that those subject to new regulation have the opportunity to comment publicly (U.S. Department of State, 2011). Through an open rule-making process, consumers and industry are informed of proposed food and medical devices legislation before they come into force. An open rule-making system engages stakeholders in regulatory dialogue and forms the basis for risk communication. All aspects of food regulation are the responsibility of a single agency. Canada, Denmark, Ireland, the United Kingdom, Germany, the Netherlands and New Zealand have all strengthened their regulators over the past decade (GAO, 2005).

Nevertheless, regulatory oversight of food is often divided between the health and agriculture sectors. Based on the international trade and cross-border distribution systems described in Chapter 1, the Committee concluded that collaboration with other regulatory agencies, both within counties and between neighbouring countries, is the first step in understanding the fundamental elements of food and medical device regulatory systems in determining the underlying characteristics of effective systems.

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