Tag Archives: pharmaceutical regulations

No Miracles Without Prior Regulatory Approval

14 Dec

The pharmaceutical industry has come a long way from the time of the corner drugstore. Instead of a friendly neighbor compounding your prescriptions from raw materials sitting on his shelf, pharmaceuticals have become a globalized industrial complex with raw material sources, production facilities, and supply chains strung all across the planet.

Compounding this problem is the brier patch of national and sometimes regional oversight agencies that produce an ever-expanding thicket of new regulations that frequently contradict those of other players in the administrative portion of the international pharmaceutical trade. Given the literal life and death nature of these products, procedural hurdles can sometimes have devastating consequences.

Countless stories have been filed about patients who have to journey to distant lands in order to receive treatments currently unapproved for use in their own countries. Large travel expenses are thus added to the costs of cutting edge medicine and further debilitate the patient’s health and ability to afford treatment.

Clearly, a single unified international pharmaceutical standard is called for. The most promising avenue of progress is probably found in the International Conference on Harmonization of Technical Requirements for Registrations of Pharmaceuticals for Human Use, or ICH for short. Many nations which have previously expressed satisfaction with their insular regulatory procedures have been getting behind this effort. Japan pharmaceutical regulations have been particularly notorious for slowing down the approved use of drugs widely prescribed in the United States and Europe. Rapid progress is now taking place, particularly on the subject of generic substitutes for approved medications.

Until the day comes when one single supra-national organization oversees the entire pharmaceutical industry, companies will have to live with the way things are today. That means staying exceptionally vigilant about both published and proposed regulatory changes in a host of different venues. Certain drugs could be legal when inserted into a national supply chain yet turn out to be unapproved by the time they reach the end user. In other cases, even exactly similar drugs already approved for market may be banned based on their point-of-origin.

From a public relations standpoint, not to mention from a legal and medical one, such an inadvertent violation could prove disastrous for company shareholders and management. To a large degree, modern pharmaceutical companies have no choice except to pursue the same prescription for both their stockholders and their customers…do no harm.