PubMed · 4833140
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C M Metzler. 1974. Bioavailability--a problem in equivalence.. https://pubmed.ncbi.nlm.nih.gov/4833140/
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The European Union's (EU) centralized procedure for new drug review was implemented in 1995 to unify the regulatory process and provide EU-wide marketing authorizations for innovative medicinal products. Goals were instituted to ensure the timeliness of the various steps of the process. The EU approved 27 biopharmaceutical products through the centralized procedure during 1995-1999. This study documents the success of the EU in meeting the timeline goals for the group and for separate categories of biopharmaceuticals (recombinant proteins, monoclonal antibodies, and antisense oligonucleotides). A subset of the 27 biopharmaceuticals approved in the EU were also approved in the United States (US). We compared EU and US approval times for these products by product category and by review status (exceptional/non-exceptional circumstance in the EU and priority/standard in the US).
With the synergistic and multiplicative interactions of rational drug design, recombinant biotechnology, combinatorial chemistry and high-throughput screening, millions of compounds are being synthesized by chemists. However, development of these drug candidates has often been impeded, if not terminated, due to biopharmaceutic and/or pharmacokinetic constraints. This has resulted in delays in development time and escalation of cost in the drug research programmes. So, the present emphasis is to reduce development time and cost, which is analogous to added patent life besides the enormous reduction in human suffering. In this compilation the important biopharmaceutic and pharmacokinetic approaches are discussed, which will help in the development of safe and more efficacious drugs with reduced development time and cost.