Healthcare, Medical and Pharmaceutical Regulations and standards: Who Does it, and for what purpose?


By Emad El Alem - Biomedresearches Publisher
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Health, Medical and Pharmaceutical companies and manufacturers compete the banking and technology sector giant’s in terms of income and profits. They contribute to the economy of their countries through tax revenue and employment, and give them a world leadership to pioneer and impose their health policies and standards. Bearing in mind, one of the most important criteria for the happiness of a citizen in his country is usually based on two important factors, which are: education and health. therefore, you may notice that any candidate for an official or public position is usually elected according to the voter's assessment of his achievements and agenda in regards to these two.
It is fair to say, in addition to the healthcare practitioners whom we see heroes in white coats during crises; there are unknown soldiers, who are the associations and health regulatory institutions and authorities which are behind the laws and regulations that manage everything related to the health and medical sector from A to Z. They are entrusted with the responsibility to ensure the safety, effectiveness and quality of everything that will be used and applied to patients, and in the health sector in general. These entities have their own specialized laboratories, scientists and specialists in various medical fields, working meticulously according to protocols that are periodically reviewed to ensure that any product is approved before it is put on the local market in their countries or across the world. As an example, let us say a medical device or a medicine, will not be granted marketing and production permission until it passes procedures, tests, clinical trials with a sequential mechanism of action that guarantees its successful passage for human or even veteran use. Otherwise, it is banned, prevented, and reported globally, so that countries and health sectors in the world avoid using it. So, from here comes the importance of Medical Regulatory and Standard Authorities.

In this article, we will review the most important and reliable medical regulatory bodies in the world, and the pioneering role they play to ensure everything related to medical, health sector, patients and practitioners are in harmony. The conditions they impose on each medical product, whether it is a device, medicine or supplies (though some of them are also entrusted with organizing the food process which we will talk about in a separate article); makes human life’s matter the most!
Let us now review together the most important international bodies, and classify them here as per my best of knowledge; my experience in the field of medical device regulatory (device compliance, field safety notice, recalls and adverse events); and as well from my continuous review of their reports and activities. Please note that every country has its own regulatory authority, which is responsible to set locally the regulations to be followed by manufacturers, marketers, distributers, and healthcare facilities, and enforce their compliance to its guidelines.
Note: In the below list, intentionally, I did not include nor talked about regulatory authorities such as: 'CE', 'UL', 'GS', 'TUV' etc. as I believe these even though certifies medical devices, but on the basis of electrical safety ratings. They do not certify them in the same manner the medical and health regulatory authorities do. The same principle of non-list inclusion is applied to 'ISO', 'ECRI', 'JCAHO', 'NCQA', 'JCI' and others (they are more concerned for administrative and organizing criteria).

Food and Drug Administration (FDA)

Among global regulators, FDA in my opinion is the best, and the most efficient and reliable health and medical regulatory authority in the world. In fact, many of the country’s regulator authorities follow practically the foot steps of FDA, and therefore, whatever FDA decides, they implement and follow.
Here is what FDA says about its mission:

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

EU Medical Devices - Sector

EU Medical Devices Sector is the European regulatory framework, which ensures the safety and efficacy of medical devices and facilitates patients access to devices in the European market. EU Medical Devices Sector On 5 April 2017 issued two new Regulations on medical devices, and in vitro diagnostic medical devices, establishing a modernized and more robust EU legislative framework to ensure better protection of public health, and patient safety were adopted.
Here is what they say about their task:

Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. The EU has a competitive and innovative medical devices sector, characterized by the active role of small and medium-sized enterprises. It is supported by a regulatory framework that aims to ensure the smooth functioning of the internal market, taking as a base a high level of protection of health for patients and users. There are over 500 000 types of medical devices and IVDs on the EU market. The medical devices sector is essential to the provision of healthcare to citizens and is an important player in both the European and global economy.

European Medicines Agency (EMEA)

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.
Here is what it says about itself:

The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU). EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients. The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.

Japan Pharmaceuticals and Medical Devices Agency (PMDA)

Japan PMDA is an independent administrative institution responsible for ensuring the safety, efficacy and quality of pharmaceuticals and medical devices in Japan..
Here is what I found about it from the net, which describes its tasks:

Among the tasks the agency is responsible for: Drug and medical device testing; Scientific review of market authorization applications based on Japanese pharmaceutical law; Advice in clinical trials or in the preparation of dossiers for the registration procedure; Inspection and conformity assessment of good clinical, programs practice; Auditing of manufacturers to ensure they conform to Good Manufacturing Practice; Post-marketing drug safety: The collection, analysis and distribution of data on the quality, efficacy, and safety data of medicines and medical devices; Advising consumers on approved products; Research on the development of industry standards; Victim compensation.

Health Canada - Health Products and Food Branch (HPFB)

The Health Products and Food Branch's (HPFB) is the Canadian government agency responsible to manage the health-related risks and benefits of health products and food in the Canadian territories. They promote the health and safety by being a trusted scientific and regulatory authority for health products and food in Canada and internationally.
Here is what they say about their mission:

The Health Products and Food Branch evaluates and monitors the safety, quality and efficacy of health products (including pharmaceutical, biological and radiopharmaceutical drugs, medical devices, natural health products, foods, veterinary drugs). They are developing, promoting, and implementing nutrition and food policies and standards, and providing timely, evidence-based, authoritative information to allow healthy and informed decisions. They anticipate and respond to public health and safety issues associated with health products, food, and nutrition.

The Australian Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
Here is what they say about their mission:

As part of the Department of Health, the TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods. The TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods. The TGA regulates therapeutic goods through: pre-market assessment, post-market monitoring and enforcement of standards, licensing of Australian manufacturers and verifying overseas manufacturers' compliance with the same standards as their Australian counterparts

UK Medicines and Healthcare Products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
Here is what they say about their mission:

MHRA is an executive agency, sponsored by the Department of Health and Social Care. The agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development. The agency has 3 centers: the Clinical Practice Research Datalink (CPRD), a data research service that aims to improve public health by using anonymized NHS clinical data; the National Institute for Biological Standards and Control (NIBSC), a global leader in the standardization and control of biological medicines; the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulator of medicines, medical devices and blood components for transfusion, responsible for ensuring their safety, quality and effectiveness.

The Federal Institute for Drugs and Medical Devices in Germany (BfArM)

(BfArM) is an independent federal higher authority within the portfolio of the Federal Ministry of Health. involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors.
Here is what they say about their mission:

The most important aim of (BfArM) activities is to increase the safety of medicinal products and thus that of the patients. Consequently, the BfArM makes a major contribution towards the prevention of risks to public health. In addition, it provides high-quality information for all areas of the health system via Internet.