Pharmaceutical regulations are established to ensure the safety, efficacy, and quality of manufactured drugs. This is achieved through a wide range of regulatory activities throughout the drug’s lifecycle.
The controls and inspections conducted to oversee drug manufacturing are far more stringent than those in other sectors, such as the food industry.
When we take a drug or inject it directly into our bloodstream, we bypass many of the body’s natural defense mechanisms that protect us from harm, leaving us terribly vulnerable to even the slightest defect or impurity in the drug’s production.
Therefore, the public, patients, and medical professionals must be confident that:
The drug manufacturer has produced the drug with the utmost care and safety, ensuring no flaws in the production process or raw material supply that could affect the stability, quality, or purity of the final product.
However, it is impossible for a medical professional, or even the consumer, to determine whether a supplied pharmaceutical product is safe and effective. Even the smallest changes in the production process can have potentially fatal consequences for patients.
The primary burden of ensuring consumer safety lies in the production stage, where effective regulations must guarantee that drugs are safe and effective.
Good Manufacturing Practice (GMPs)
Good Manufacturing Practice (GMPs) is a set of rules requiring drug manufacturers to ensure their products are safe, pure, and effective.
GMP covers all aspects of production, from raw materials, facilities, and equipment to the training and personal hygiene of staff. Detailed written procedures must exist for every process that could impact the quality of the final product, and these procedures must be strictly followed throughout all stages of drug production.
The United States, Europe, Japan, China, India, the United Kingdom, the World Health Organization (WHO), and others each have their own specific versions of GMPs. The regulations a manufacturer must follow depend on the location of the production facility and the market where the drug is supplied to patients.
In addition to GMPs, pharmaceutical companies must also adhere to quality systems, quality standards, and guidelines from other industrial and international bodies. Below, we will explore the most significant regulatory and industrial frameworks, quality standards, and systems, along with the organizations responsible for them.
Food and Drug Administration (FDA)
The Food and Drug Administration (FDA or USFDA) is an agency of the U.S. Department of Health and Human Services, responsible for protecting and promoting public health in the United States by regulating and supervising the safety of food, tobacco products, dietary supplements, prescription and over-the-counter drugs, vaccines, biologics, medical devices, cosmetics, veterinary products, and more. The FDA inspects manufacturers worldwide to ensure compliance with current Good Manufacturing Practices (cGMP) for any product intended for the U.S. market. The FDA provides guidelines for manufacturers in the Code of Federal Regulations, requiring companies to adopt acceptable approaches and meet requirements for producing drugs and vaccines.
European Medicines Agency (EMA)
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), established in 1995. It is responsible for the evaluation, supervision, and safety monitoring of pharmaceutical products manufactured for use in the EU. EU regulations mandate that all drug manufacturers comply with EU Good Manufacturing Practices (GMPs) if they wish to supply products to the EU. Manufacturers and importers must be registered and licensed by a competent authority of an EU member state and are subject to regular inspections by an EU competent authority or other approved bodies to verify compliance with EU GMPs. The frequency of inspections is based on risk assessments. Additionally, the local competent national authority must provide written certification confirming that each batch of manufactured products complies with GMPs.
Pharmaceuticals and Medical Devices Agency (PMDA)
The Pharmaceuticals and Medical Devices Agency (PMDA) is an independent entity in Japan responsible for ensuring the safety, efficacy, and quality of drugs and medical devices. For pharmaceutical products and medical devices, the PMDA audits manufacturers to ensure compliance with Good Manufacturing Practices (GMP) and the maintenance of an appropriate Quality Management System (QMS).
International Council for Harmonization (ICH)
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established in 1990 to bring together the pharmaceutical industries and regulatory authorities of the United States, Europe, and Japan—the primary markets for major companies—to develop comprehensive regulations from a scientific and technical perspective. For example, this allows an American manufacturer to sell its products in Europe without requiring the European regulatory authority to audit the U.S. production facility, and vice versa, as regulatory bodies often accept inspection findings from one another. This reduces redundant oversight, making drugs more cost-effective and increasing access for more people. The ICH has developed various guidelines, including:
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ICH Q7: Guidelines for Good Manufacturing Practices for Active Pharmaceutical Ingredients
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ICH Q8: Pharmaceutical Development
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ICH Q9: Quality Risk Management
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ICH Q10: Pharmaceutical Quality Systems
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ICH Q11: Development and Manufacture of Drug Substances
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
PIC/S is a non-binding, informal cooperative arrangement between regulatory authorities in the field of Good Manufacturing Practices (GMP) for pharmaceutical products intended for human or veterinary use. It is open to all regulatory authorities with a GMP inspection system and currently comprises 54 countries worldwide (from Europe, Africa, the Americas, Asia, and Australia). The goal of PIC/S is to harmonize inspection procedures globally by developing common GMP standards and providing training opportunities for inspectors. It also aims to facilitate cooperation and networking among competent authorities, regional and international organizations, and build mutual trust. PIC/S publishes a range of regulatory guidelines and recommendations online.
World Health Organization (WHO)
The World Health Organization (WHO) is a specialized agency of the United Nations (UN) focused on international public health. Established on April 7, 1948, in Geneva, Switzerland, WHO is a member of the UN Development Group. It leads global efforts to expand universal health coverage, striving for health for all through science-based policies and programs.
In technology transfer processes, there must be sufficient mastery of the regulations governing the production of biologic drugs. These regulations are strict rules that ensure the efficacy and safety of biosimilars. In Iran, domestic regulations for the production of biologic drugs can be accessed from the Food and Drug Organization’s website
