The regulation of biological products.
The purpose of regulations for biological products is the same as that for any other medicinal or related products: the protection of recipients of the products. The entry into the age of molecular biology with its attendant development and manufacturing technology has placed new demands on regulatory agencies and related industry personnel. While the general goals of regulations remain the same, the scientific bases by which biological products must be reviewed and registered vary from those traditionally used for drugs or even older vaccines produced by conventional methods of growth, harvesting and purification. New regulations must be developed which take into account the new science involved in molecular biology and recombinant technology; new definitions must be provided and widely understood. The regulation of biologic products on an international basis is complicated by issues such as national interests superceding individual patient needs, bureaucracies being driven primarily by regulation and secondarily by science, industry expecting priority treatment for innovative products while having to absorb costs related to lost regulatory review time, and agencies or industry relying upon outdated regulations and/or archaic tests.(ABSTRACT TRUNCATED AT 250 WORDS)
Brown
K R
KR
Regulatory Affairs, Merck Sharp & Dohme Research Laboratories, West Point, Pennsylvania 19486.
D001709:Biotechnology / Q000331:legislation & jurisprudence*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D011994:Recombinant Proteins; D015203:Reproducibility of Results; D014481:United States; D014614:Vaccines, Synthetic
D011994:Recombinant Proteins; D014614:Vaccines, Synthetic