Glossary

The term generic product has somewhat different meanings in different jurisdictions. The use of this term is therefore avoided as much as possible, and the term multisource pharmaceutical product (see below) is used instead. Generic products may be marketed either under the approved nonproprietary name or under a brand (proprietary) name. They may be marketed in dosage forms and/or strengths different from those of the innovator products (see below). Where the term generic product is used, it means a pharmaceutical product, usually intended to be interchangeable with the innovator product, which is usually manufactured without a licence from the innovator company and marketed after expiry of the patent or other exclusivity rights. The term should not be confused with generic names for active pharmaceutical ingredients.

GHTF was conceived in 1992 in an effort to achieve greater uniformity between national medical device regulatory systems. The aims were to enhance patient safety and increase access to safe, effective and clinically beneficial medical technologies around the world. A partnership between regulatory authorities and regulated industry, it consisted of five Founding Members. These were: Australia, Canada, Japan, United States and the European Union. GHTF no longer exists but its work is continued by the International Medical Device Regulators Forum.

A standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analysis, reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical product (diagnostic, therapeutic or prophylactic) under investigation are properly documented.

A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.

That part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

Acronym for the group of good practice guides governing the preclinical, clinical, manufacturing, testing, storage, distribution and post-market activities for regulated pharmaceuticals, biologicals and medical devices, such as good laboratory practices, good clinical practices, good manufacturing practices, good pharmacovigilance practices and good distribution practices.

The measured volume of the airspace inside the internal compartment of the appliance with the door or lid shut. For combined appliances the gross freezer volume and the gross refrigerator volume are reported separately.