Biomedical subjects

S Kopp-Kubel

Publications and source records attributed to S Kopp-Kubel.

2 recordsLinked to original sources

PubMed1995

International Nonproprietary Names (INN) for pharmaceutical substances.

WHO has a constitutional mandate to "develop, establish and promote international standards with respect to biological, pharmaceutical and similar products". The Organization collaborates closely with national nomenclature committees to select a single name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical. To avoid confusion, which could jeopardize the safety of patients, trade-marks should neither be derived from INNs nor contain common stems used in INNs. Recent developments in pharmacological research and biotechnology are challenges for the nomenclature committee. New schemes and concepts are being developed, for example, for naming monoclonal antibodies and other recombinant compounds.

Drugs, Generic↗

PubMedDate not supplied

Compendial issues: WHO.

It is important to remember that: 1. WHO is an international organization representing 182 member countries. 2. WHO has a constitutional mandate inter alia to "develop, establish and promote international standards with respect to biological, pharmaceutical and similar products." 3. Its present programme covers such activities as WHO Good Manufacturing Practices, the International Pharmacopoeia, International Nonproprietary Names (INN), WHO Certification Scheme, the Model List of Essential Drugs and many other subjects concerning safety, efficacy and quality. 4. Emphasis is now directed to the feasibility of further harmonization of requirements for drug registration and quality control having regard to the number of countries with increasing manufacturing facilities.

Certification↗