The Drug development process - Pharmaceutical Biotechnology: Concepts and Aapplications

Biomedical Engineering Reference

In-Depth Information

4.14.10 World harmonization of drug approvals

There is a growing trend in the global pharmaceutical industry towards internationalization.

Increasingly, mergers and other strategic alliances are a feature of world pharmaceutical activity.

Many companies are developing drugs that they aim to register in several world regions. Differ-

ences in regulatory practices and requirements in these different regions considerably complicate

this process.

Development of harmonized requirements for world drug registrations would be of considerable

benefi t to pharmaceutical companies and to patients, for whom many drugs would be available

much more quickly.

The International Conference on Harmonization (ICH) process (of technical requirements for

registration of pharmaceuticals for human use) brings together experts from both the regulatory

authorities and pharmaceutical industries based in the EU, USA and Japan. The aim is to achieve

greater harmonization of technical/guidelines relating to product registration in these world re-

gions, and considerable progress has been made in this regard over the last decade. The 'mem-

bers' comprising the ICH are experts from the European Commission, the European Federation

of Pharmaceutical Industries Association, the Ministry of Health and Welfare, Japan, the Japa-

nese Pharmaceutical Manufacturers Association, the FDA and the Pharmaceutical Research and

Manufacturers of America. The ICH process is supported by an ICH secretariat, based in Geneva,

Switzerland.

4.15 Conclusion

The drug discovery and development process is a long and expensive one. A wide range of strate-

gies may be adopted in the quest for identifying new therapeutic substances. Most biopharmaceu-

ticals, however, have been discovered directly as a consequence of an increased understanding of

the molecular mechanisms underlining how the body functions, both in health and disease.

Before any newly discovered drug is placed on the market, it must undergo extensive testing,

in order to assure that it is both safe and effective in achieving its claimed therapeutic effect. The

data generated by these tests (i.e. preclinical and clinical trials), are then appraised by independ-

ent, government-appointed regulatory agencies, who ultimately decide whether a drug should gain

a marketing licence. While the drug development process may seem cumbersome and protracted,

the cautious attitude adopted by regulatory authorities has served the public well in ensuring that

only drugs of the highest quality fi nally come on to the market.