Biopharmaceuticals approval requirements

The PAB undertakes drug dossier evaluations, a process that normally takes 18 months. The approval requirements/process for pharmaceuticals (including biopharmaceuticals) are, in broad terms, quite similar to the USA. The PAB have issued specific requirements (Notification 243) for submission of recombinant protein drugs. 

The design of pharmacokinetic studies that need to be conducted for product approval is a function of how much is known about the active drug moiety, its clinical pharmacokinetics, and the biopharmaceutical properties of the dosage form, and regulatory requirements. As a minimum,... 

For an extended-release dosage form, at least three test time points are chosen to characterize the in vitro drug-release profile for the routine batch-to-batch quality control for approved products. Additional sampling times may be required for formulation development studies, biopharmaceutical evaluations, and drug approval purposes. An early time... 

To date, most approved protein-based drugs are for therapeutic or replacement therapies. They are recombinant versions of natural proteins such as insulin and erythropoietin. Their characteristics and functions are relatively well defined and known. The next phase of biopharmaceuticals, such as antibodies and vaccines, is more complex and requires more tests and characterizations. Controls for the reliability, contamination, and fidelity of expression systems will be high on the agenda in the coming decade. 

Before 1996 the FDA approved biopharmaceuticals through a dual process that required a Product License Applica-... 

While no biopharmaceutical is approved with the requirement of genotyping as a part of its therapeutic indication, a recently approved monoclonal antibody therapy against breast cancer, trastuzumab (Herceptin), is indicated only for those tumors measurably expressing the protein expressed by the gene erbB-2. Because the oncogene product of erbB-2 is elevated... 

A common misconception of pharmaceutical and especially smaller biopharmaceutical companies is that the implementation of a robust QMS is not required in areas other than commercial manufacturing. Small, biotech start-up companies also tend to delay the implementation of well-designed processes until they near the approval stage, focusing the organization instead for product approval or sale. This... 

Centralized Procedure (CP) This is the procedure of most interest for biopharmaceuticals, as this is the mandatory route for review and approval of such drugs in the European Union. In the centralized procedure a single application is submitted to the European Medicines Agency (EMEA). A variety of presubmission activities, starting six months before the intended start date of the centralized procedure, are required [8], Two initial assessments by a Rapporteur and Co-rapporteur national authorities (one from each of two member states chosen by the EMEA) are made, leading to Day 80 Critical Assessment Reports. A consolidated list of questions (LoQ) is provided to the applicant at Day 120 when there is a clock stop, normally of three months, to allow the preparation and submission of responses. Following satisfactory negotiation of other steps in the procedure, the Committee on Human Medicinal Products will recommend authorization at Day 210, with authorization by the Commission at Day 277. 

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