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Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Pharmacovigilance, also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions (ADR), which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).
Under European Union (EU) law, the qualified person (QP) is responsible for certifying that each batch of a medicinal product meets all required provisions when released from a manufacturing facility within the EU, or imported into the EU. Such provisions include that the batch was manufactured under appropriate standards, and that it passed all required testing.
The European Chemicals Agency is an agency of the European Union working for the safe use of chemicals. It manages the technical and administrative aspects of the implementation of the European Union regulation called Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). ECHA is the driving force among regulatory authorities in implementing the EU's chemicals legislation. ECHA has to ascertain that companies comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern. It is located in Helsinki, Finland. ECHA is an independent and mature regulatory agency established by REACH. It is not a subsidiary entity of the European Commission.
EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
EudraCT is the European Clinical Trials Database of all clinical trials of investigational medicinal products with at least one site in the European Union commencing 1 May 2004 or later. The EudraCT database has been established in accordance with Directive 2001/20/EC. The EudraCT Number is unique and is needed on other documents relating to the trials.
The Clinical Trials Directive is a European Union directive that aimed at facilitating the internal market in medicinal products within the European Union, while at the same time maintaining an appropriate level of protection for public health. It seeks to simplify and harmonise the administrative provisions governing clinical trials in the European Community, by establishing a clear, transparent procedure.
The Good Clinical Practice Directive lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
EUDRANET, the European Telecommunication Network in Pharmaceuticals, is an IT platform to facilitate the exchange of information between regulatory partners and industry during submission and evaluation of applications. The aim of EUDRANET is to provide appropriate secure services for inter-Administration data interchange and for exchanges between Administrations and industry. EUDRANET is based on the TESTA backbone infrastructure provided by the IDA Programme.
EudraPharm was the database of medicinal products authorised in the European Union, and included the information contained in the Summary of Product Characteristics, the patient or user package leaflet and the information shown on the labelling. The EudraPharm database was accessible to the general public and the information thus made available was worded in an appropriate and comprehensible manner. It was decommissioned in 2019.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
The European Directive on Traditional Herbal Medicinal Products (THMPD), formally the Directive 2004/24/EC amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use, was established by the European Parliament and Council on 31 March 2004 to provide a simplified regulatory approval process for traditional herbal medicines in the European Union (EU). Previously, there was no formal EU wide authorisation procedure, so each EU member state regulated these types of products at the national level.
The certificate of pharmaceutical product is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; it is often mentioned in conjunction with the electronic Common Technical Document (eCTD). A CPP is issued for a single product, because manufacturing arrangements and approved information for different pharmaceutical forms and strengths can vary. The CPP is mentioned in World Trade Organization documents, although the tightly regulated products are subject to bilateral trade agreements or regional trade agreements. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has instituted standards for this purpose but it is unclear how the ex-ICH countries operate their health regulators.
The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.
The rapid development in the multidisciplinary field of tissue engineering has resulted in a variety of new and innovative medicinal products, often carrying living cells, intended to repair, regenerate or replace damaged human tissue. Tissue engineered medicinal products (TEMPs) vary in terms of the type and origin of cells and the product’s complexity. As all medicinal products, the safety and efficacy of TEMPs must be consistent throughout the manufacturing process. Quality control and assurance are of paramount importance and products are constantly assessed throughout the manufacturing process to ensure their safety, efficacy, consistency and reproducibility between batches. The European Medicines Agency (EMA) is responsible for the development, assessment and supervision of medicines in the EU. The appointed committees are involved in referral procedures concerning safety or the balance of benefit/risk of a medicinal product. In addition, the committees organize inspections with regards to the conditions under which medicinal products are being manufactured. For example, the compliance with good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP) and pharmacovigilance (PhV).
The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.
Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.
References
- ↑ EudraGMP.EMA. 2007. Web November 13, 2013. http://eudragmdp.ema.europa.eu/
- ↑ Robinson, Derek. “Regulatory Highlights from February – July 2011.” Organic Process Research & Development. (2011):15;970-973.
- ↑ Robinson, Derek. “Regulatory Highlights for September 2009 to February 2010.” Organic Process Research & Development. (2010):14;323–327