Finished Product Labeling and Packaging Guidelines
To provide guidance on how to make sure the information on labels and package leaflets is accessible to patients and understandable, the Drug Regulatory Authority of Pakistan (DRAP) developed guidelines for labeling and packaging finished drug products and is now seeking feedback on the same.
DRAP aims to ensure that medicines are used safely, to make labeling and packaging more consistent, clear, efficient, efficient, and high quality, and to help marketing authorization holders create leaflets.
The DRAP has developed a draft that describes the information that should be displayed on a product label, such as the registered name of the drug, as well as how requirements differ based on whether the medicine is for internal, external, or parenteral use, as well as rules for government-supplied drugs, products in pressurized containers, and physician's samples.
Furthermore, the draft details the issue of brand names and urges the pharmaceutical companies to avoid names that could confuse other medicinal products and also ban names that convey misleading therapeutic connotations or promotional messages.
Click on this LINK to know more detailed information on the draft bioavailability bioequivalence guidelines
Bioavailability Bioequivalence Guidelines
The document asserts that in vivo and in vitro tests ensure interchangeability between generic and reference products.
The draft guidance primarily addresses in vivo studies, including study standardization and how to approach trials of immediate- and modified-release formulations.
Click on this LINK to know more detailed information on the draft bioavailability bioequivalence guidelines
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