Regulatory procedures for emergency approval of medical products by regulatory agencies

Emergency use authorization of medical products by the regulatory agencies is not a usual procedure; it happens to cope with unanticipated health emergencies affecting a large group of population, these can be because of outbreak agents like virus, bacteria, etc., which can cause contagious diseases. Contagious diseases are classified into an outbreak, epidemic and pandemic disease, based on size and intensity of spread of the disease. Epidemic and Pandemic disease conditions such as CoVID-19 will trigger the emergency use authorization of products that help in the control, prevention and/or cure for the disease. EMA and FDA are well known advanced regulatory bodies, with eminent procedures for approval of the medication, harmonization of the standards as per the global regulatory acceptance. However, there are some differences between the two, in case of initiating the procedure, timelines, data required for approval of products under the emergency use. This article focuses on emergency approval of medications, regulations involved in the approval of medications and vaccines by EMA and FDA, some of the important data companies or sponsors need to submit to the regulatory bodies for approval, verification procedure and timelines for evaluation of manufacturer submitted data. Mutual recognition agreement and timeline of Remdesivir for approval by EC and FDA.

The Israel-PLO Mutual Recognition Agreement

From the perspective of a practitioner who was deeply engaged in the negotiations, this article describes how the Israeli-Palestinian Mutual Recognition Agreement was conceived and negotiated. It explains the process of convincing Israeli and Palestinian leaders to accept mutual recognition, overcoming their initial objections. While not nearly as publicized as the 1993 Declaration of Principles agreed at Oslo, this Agreement became the bedrock for all the Oslo Accords, and set the stage for subsequent negotiations.

State industrial policy in conditions European integration of Ukraine

Since the beginning of 2020, there have been crisis phenomena around the world due to the global slowdown in economic growth and the introduction of quarantine due to the coronavirus pandemic. In this situation, the most vulnerable are developing countries with a small margin of safety, which, unfortunately, also applies to Ukraine, whose economy is open and highly dependent on external markets. Due to the slowdown in the growth of the global economy, the situation in one of the main export industries of Ukraine – industry is deteriorating first of all. The European Union has become one of the important export markets for Ukraine’s industrial products in recent years, which has raised the issue of shaping a relevant state industrial policy in today’s challenging environment. The purpose of the article is to determine the directions of formation and implementation of state industrial policy in the conditions of European integration of Ukraine in modern conditions. In 2020, due to the economic crisis and the pandemic of the coronavirus, the Ukrainian industry may lose even more due to low demand for ferrous metals in world markets, including in EU countries. The Agreement on Conformity Assessment and Acceptance of Industrial Products is a way of eliminating technical barriers to trade between Ukraine and the EU. The Agreement on Conformity Assessment and Acceptance of Industrial Products is a type of mutual recognition agreement that requires a partner country to align its legislation, practices and infrastructure with EU rules.It is envisaged that in the sectors covered by this Agreement, Ukrainian exporters will be able to label their products with the CE mark and to sell them freely on the EU market without additional EU certification. Potentially, the Agreement on Conformity Assessment and Acceptance of Industrial Products could cover up to a fifth of Ukraine’s exports to the EU, notably mechanical engineering products. The formation and implementation of state industrial policy in the conditions of European integration of Ukraine should take place using the following algorithm:1. Study of the new EU Regulation 2019/1020 of 20.06.2019 on market surveillance and conformity of products and elaboration of relevant amendments to the legislation of Ukraine.2. Concentration of the function of legal coordination of draft regulatory acts (including technical regulations) aimed at implementing the Association Agreement and preparation for the Agreement on Conformity Assessment and Acceptance of Industrial Products in one state instance, equipped with specialized personnel with adequate knowledge of EU law and languages.3. Strengthening the requirements for the accreditation and oversight process for accredited bodies, as well as the process of designating and monitoring conformity assessment bodies to ensure that their technical competence is adequate and to prevent fraud and the use of fraudulent practices.4. In the absence of a rapid prospect of concluding an Agreement on Conformity Assessment and Acceptance of Industrial Products, the harmonization of procedures and requirements that are too burdensome for exporters and importers, first and foremost.5. Paying particular attention to capacity building of state market surveillance authorities.6. Raising awareness of business entities and enhancing the role of business associations in raising such awareness.7. Increasing the EU’s interest in providing Ukraine with effective technical assistance for the development of legislation and the proper functioning of quality infrastructure and market surveillance authorities. Introduce the position of Deputy Prime Minister for Industry and launch support programs for the real economy. Thus, Ukraine’s further integration with the European Union is largely linked to the formulation and implementation of relevant industrial policy, which should be to continue reforming all sectors of the economy, in particular, to modernize the industrial complex. And the signing of the Agreement on Conformity Assessment and Acceptance of Industrial Products in the three priority sectors («industrial visa waiver») in the medium term should become one of the main foreign economic priorities of Ukraine’s European integration in the face of the current challenges of today.

Regulatory Cooperation in Securities Market Regulation: Perspectives from Australia

The global financial crisis highlighted the interconnectedness of international financial markets and the risk of contagion it posed. The crisis also emphasized the importance of supranational regulation and regulatory cooperation to address that risk. Yet, although capital flows are global, securities regulation is not. As a 2019 report by IOSCO notes, the regulatory challenges revealed during the global financial crisis have by no means dissipated over the last decade. Lack of international standards, or differences in the way jurisdictions implement such standards, can often result in regulatory-driven market fragmentation. This article considers a range of cooperative techniques designed to achieve international regulatory harmonization and effective financial market supervision. It includes discussion of a high profile cross-border supervisory experiment, the 2008 US-Australian Mutual Recognition Agreement, which was the first agreement of its kind for the SEC. The article also examines some key regulatory developments in Australia and Asia since the time of the US-Australian Mutual Recognition Agreement.

International Athletic Training and Therapy: Comparing Partners in the Mutual Recognition Agreement

Context The globalization of athletic training and therapy is advancing and professionals have more opportunities to transition to international working environments. Objective To compare the American, Canadian, and Irish athletic training and therapy education, accreditation, and certification processes. Background The Mutual Recognition Arrangement recognized the equivalency of athletic training and therapy in the United States, Canada, and Ireland, and thereby provides an avenue for nationally credentialed professionals to obtain equivalent credentials in one of the aforementioned countries. Synthesis As a comparison, this article demonstrated that there was a commonality among countries, but also highlighted the unique jurisdictional differences that our members should be aware of should they want to transition to partner countries. Results We performed a comparative analysis of the education, accreditation, and certification processes among the United States, Canada, and Ireland. Specific differences were noted among supervision methods, clinical education methods, and certification exams. All of these are grounded in the Mutual Recognition Agreement. Recommendation(s) We recommend that the Mutual Recognition Agreement be held as a basis for future partnerships with other countries. Conclusion(s) This article provided an overview and highlighted the similarities among academic education, domains, and content areas covered under the Mutual Recognition Agreement among athletic training and therapy programs in the United States, Canada, and Ireland. The education programs, accreditation procedures, and certification systems, although differing in structure, were consistent in delivering content that aligns with the Mutual Recognition Agreement.

Application of Chow Test to Estimate the Effect of Mutual Recognition Agreements

This article presents the research results on Mutual Recognition Agreement effect on the volume of exports – imports of the countries (parties) in the context of the EU – Israel Mutual Recognition Agreement. The authors used the Chow test to obtain the results. The article shows that there is no good reason to believe that Mutual Recognition Agreements boost the volume of mutual trade, at least, of pharmaceutical products. In other words, Mutual Recognition Agreements do not contribute to the growth in the number of exporters. It is concluded that the primary effect of such agreements is to facilitate conformity assessment procedures.