Regulatory CMC Changes for Pharmaceutical Products

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Regulatory CMC Changes for Pharmaceutical
Products
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Regulatory CMC Changes for Pharmaceutical Products

• All the biopharmaceutical companies must follow
  respective nations laws or regulations in order
  to develop, manufacture and sale their
  pharmaceutical products. Before any
  biopharmaceutical product goes in to market, it
  has to get marketing authorization from the
  relevant health authorities. Market authorization
  is issued on the basis of an assessment of
  submitted information that describes the quality,
  safety and efficacy of the product for a
  specified indication.

Applicants and manufacturers often implement
changes in the product, production process,
quality controls, equipment, facilities,
responsible personnel, or labeling established in
an approved application for licensed biological
products for a variety of reasons. As a result of
global regulatory requirements, many changes
cannot be implemented until health authority
reviews and approves them. Health authorities
often have several questions during their reviews
for which a manufacturer needs to prepare for
many rounds of responses. Multiple reviews of the
same information can lead to high costs Read
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