Renovation of ttie new medicine regulatory process

摘要

As we near the end of the first decade of the 21st century, it is obvious that the discovery, development, and commercialization of new medicines is a dynamic process that has become vastly more complicated than it was even a few years ago. It is an international process involving companies located in many different countries, clinical trials performed in even more countries and academic contributions from around the world. There are many hundreds of drugs in clinical development. They are representatives of multiple technologies and chemical classes including small molecules, monoclonal antibodies, other proteins, anti-sense oligonucleotides, aptamers, and gene therapy, and, perhaps in the near future, stem cell-based therapeutics. These clinical trials are sponsored by very large multinational pharmaceutical and biotechnology companies with very substantial experience, generic companies, traditional regional companies expanding toward worldwide markets, and biotechnology companies that range in size and competency from very large and experienced to virtual with virtually no experience. The trials are, in fact, often conducted by contract research organizations that again vary widely in size, competency, and experience. All of this is managed by a very tmeasy collaboration between the industry, academic medicine, and regulatory agencies.