Agencies / Regulatory & Organisations

Australia – TGA

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods. They carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances.

Quality guidelines

Brazil – ANVISA

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others. The agency is connected to the Ministry of Health, which manages ANVISA through a management contract signed periodically.

MP Guide Part I Basic Requirements for Medicinal Products

Cosmetic Ingredient Review

The Cosmetic Ingredient Review was established in 1976 by the industry trade association (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Care Products Council), with the support of the U.S. Food and Drug Administration and the Consumer Federation of America. Although funded by the Council, CIR, the Expert Panel for Cosmetic Ingredient Safety, and the review process are independent from the Council and the cosmetics industry. CIR and the Expert Panel for Cosmetic Ingredient Safety operate under a set of procedures.

ECA – European Compliance Academy

The ECA Academy is the educational organisation established by the ECA Foundation. It develops and organises a wealth of international education courses, conferences (also as part of a GMP Certification Programme) and webinars around GMP and regulatory compliance, picking up emerging GMP challenges and currently discussed subjects. While courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc, European conferences are organised as discussion forums on new trends and developments.

European association with regard to pharmaceutical Quality Assurance and GMP compliance

Europe – EMA

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It began operating in 1995. The Agency is responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a market of over 500 million people living in the EU.

European Medicines Agency – Quality – Excipients

Draft Guideline on the use of phthalates as excipients in human – 25 April 2013

Guideline on excipients in the dossier for application for marketing authorization of a medicinal product – June 2007

Excipients in the label and package leaflet of medicinal products for human use – July 2003

EUPFi – European Pediatric Formulation Initiative

The European Paediatric Formulation Initiative (EuPFI) was founded in 2007 by a group of members from Pharmaceutical industries, hospital and academics interested in research in children medicines to formulate better medicines for children. The main objective of the members was to resolve scientific, regulatory and technological issues associated with paediatric formulation development. Since its establishment, it has now evolved from a club of members to a consortium of 14 institutions working in a pre-competitive way on paediatric drug formulations.

EXCiPACT

Regulators require excipient users to qualify their suppliers based on GMP/GDP audits and they have indicated that third party auditing of suppliers is acceptable if a creditable certification body issues certificates and audit reports by employing qualified auditors who are demonstrably credible in suitable GMP/GDP standards and in the needs of the pharmaceutical industry. EXCiPACT asbl is a non-profit organisation that owns and manages oversight of such an independent, high quality, third party Certification Scheme available to pharmaceutical excipient manufacturers and distributors worldwide.

List of certified companies

EXCiPACT-Standards

FDA

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 our nation’s 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. FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.

Drug Master File List

Inactive Ingredient Search for Approved Drug Products

Generally Recognized as Safe (GRAS)

FinnBrit Consulting

Pharmaceutical products have complex and extended development cycles with an absolute minimum of at least five years for a new innovator product, and more than 3 years for a generic drug. Every extra day prior to launch costs money! FinnBrit Consulting has the necessary experience to guide you through your drug development program beginning with preformulation and their subsequent process design, development and manufacturing to the eventual launch of the finished medicinal product.

Gelatine Manufacturers of Europe

GME is the voice of the European gelatine and collagen peptides industry, a growing and innovative one. Gelatine and collagen peptides are natural, sustainable and healthy ingredients, used in numerous sectors and for various applications. As a leading association comprising all the major gelatine manufacturers, GME educates and shares the best practices of its members with customers, public authorities, European and worldwide, and the media. GME is an overall active partner – and a label of quality.

Gelatine – Pharmaceutical Industry

IPEC Americas

IPEC-Americas is a U.S. trade association whose members include excipient producers, distributors, and finished drug manufacturers, as well as companies and individuals that supply other specialized services to industry segments. Over 80 U.S. companies are IPEC-Americas members. IPEC-Americas brings together diverse stakeholders that share a common objective: Safe and effective production and use of excipients.

Homepage

Excipient Qualification Guide (2008)

List of Acronyms

Regulatory Reference

IPEC Europe

A powerful voice in Europe since 1992, the International Pharmaceutical Excipients Council Europe (in short, IPEC Europe) brings producers, distributors and users of pharmaceutical excipients together in one place. We provide a welcoming environment to share experiences and knowledge to learn and to lead the future of excipients.

Homepage

Japan – JPEC Pharmaceutical Excipients Council

IPEC Japan is dedicated to furthering the mutual friendship and understanding among all of its members, to contributing to the maintenance and furtherance of the health of the people by advancement of the quality, performance, and properties of pharmaceutical excipients for heightened quality, efficacy, and safety in pharmaceutical products through the cooperation of its members and in association with related organizations, and to contributing to international accord in relation to pharmaceutical standards and specifications.

Japan – PMDA – Pharmaceuticals and Medical Device Agency

PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Their obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. They conduct scientific reviews of marketing authorization application of pharmaceuticals and medical devices, monitoring of their post-marketing safety. They are also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.

Japanese Pharmacopiea

Korea – MFDS