The formal organization of drugs and its relation to health management

Why Attend

Doctors and patients are not in a position to make decisions themselves regarding the medications used; there are specific processes for the formal regulation of medicines. This involves determining which medications are pure, stable, effective, and safe, which is the responsibility of pharmaceutical companies and the regulatory agencies overseeing drugs, as well as the rights that ensure all these aspects throughout the drug's lifecycle.

The formal regulation of medicines is crucial for health management, which focuses on delivering high-quality services and the optimal utilization of resources. Undoubtedly, the formal regulation of medicines is part of health management in pharmaceutical companies, which have the duty to ensure the quality of healthcare by fulfilling their role in producing effective and safe medications.

This course offers courses and programs in health management at all levels, as well as health and safety courses that are part of health management functions.

Course Objectives

By the end of the course, participants will be able to:

How is the formal organization of drugs in the EU? What is the relationship of drug regulation and licensing to health management?

All countries where medicines are licensed for use have regulatory devices that meet the requirements for the safety, efficacy, quality and supply of the drug, which are The FDA, the European Medicine Evaluation Agency (EMEA) and the Japanese Pharmaceutical Affairs Office, as well as the local regulators that work with these agencies and are present in each of its member states.

The official regulation of medicines in the European Union is carried out through individual member states and maintains responsibility for public health issues in their own countries. This recognition and respect for the system in Europe is important. Until 1995, the requests for authorization from these authorities were separate and this was a waste of time and human capacity, currently, the EU is licensed and regulated in three ways:

* Apply directly to the European Medicines Evaluation Agency, and then evaluate in a member government, this method is mandatory for biopharmaceuticals and optional for new pharmaceutical products.

* Nominate one of the member governments that evaluate the request and requests opinion from other Member States, and the granting of such a license will continue to be mutually recognized by these governments.

* A product marketed in a single country can apply its license through the national method of each country

After licensing the drug for sale, the future of its regulatory life remains within these three methods. Licenses are reviewed every six months in the first two years and then annually for up to five years. The renewal of the license is the responsibility of pharmaceutical companies, but it requires proof from the EMEA. This is an opportunity for companies to review, particularly on the safety of the drug, makes licensing in line with clinical practice, supported by clinical trials of its four phases, which have requirements and other matters in the formal organization of drugs.