Pharmaceutical control in EU countries, CIS, Southeast Asia

Abstract

Purpose: Research of legislation and highlight the peculiarities of pharmaceutical control in the countries of the EU, CIS,. Southeast Asia. Results: Pharmaceutical control. The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU medicines. To fulfill its mission, the European Medicines Agency (EMA) works closely with national competent authorities in a regulatory network. The Agency also implements policies and procedures to ensure it works independently, openly and transparently and support the highest standards in its scientific recommendations. In the Commonwealth of Independent States (CIS) countries the pharmaceutical control function is a component part of the Ministries of Health, or there are special departments. The Council of the Eurasian Economic Commission (RUS, BLR, KAZ, ARM, KGZ) approved a single decision to conduct pharmaceutical inspections. Thus the inspection is carried out by a pharmaceutical inspectorate on the basis of an inspection plan, an inspection request or at the request of an authorized body of a Member State. All countries in the Southeast Asia (SEA) region have a shortage of drug insurance for the population. Although progress has been made, challenges remain in delivering the right drugs at the right time. National regulatory agencies (NRAs) protect public health by ensuring the efficacy, safety and quality of medicines, but with the development of the pharmaceutical market, financial and human resources are often limited. Thus, some NRAs may legitimately decide to rely on other competent regulatory authorities to fulfill Pharmaceutical control has a common goal regardless of the country, namely ensuring the quality of the drug at all stages: production, distribution, up to marketing in pharmacies and use by the patient. National medicines policies and laws are the basis for good governance and coordination in the pharmaceutical sector. An effective national drug policy establishes the state's commitment to ensuring equitable access to effective, safe and quality medicines.