Pharma Drugs Markets, Regulatory Authorities. (22)

To sell the pharmaceutical product in any country, your manufacturing plant will inspect by the respective country’s regulators’ authority. Then these regulators’ authorities provide an Approval certification to the manufacturing plant for a certain time period. Then formulation plant authorizes to manufacture the pharmaceutical product for the respective country.

Market name                                  Regulatory authority Name

WHO                                                     World Health Organization GMP certification

India                                                    CDSCO GMP certification

United States                                     (United States Food & Drug Administration)

United Kingdom                               (The Medicines and Healthcare products Regulatory Agency)

Russia                                                Russian GMP

Brazil                                                 ANVISA (The National Health Surveillance Agency)

Australia                                            TGA (Therapeutic Goods Administration)

European Union                               EU GMP (European Medicines Agency)

PIC/S                                                 PIC/S (The Pharmaceutical Inspection Co-operation Scheme)

Taiwan                                               TFDA ( Taiwan Food and Drug Administration)

All regulatory Authorities will audit/Re-inspect every pharmaceutical formulation plant within a specific time interval (Once in 2 or 3 years) and provide non-compliances report & Approval. Also, every county has its pharmacopeia like IP, USP, BP Etc.

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