Standards

Canadian Standards You Can Trust

In Canada, pharmaceutical products are regulated by Health Canada.

 

Pharmascience takes extreme care to ensure that any externally sourced, manufactured ingredient or component of the final product meets Health Canada’s Standards.

 

All the generic products we produce are manufactured according to current Good Manufacturing Practices (cGMP) and are approved as bioequivalent to the reference product.

International Standards

ICH

International Council for Harmonization of Technical Requirements for Pharmaceutical for Human Use (ICH)

The International Council for Harmonization (ICH) has 8 regulatory members including the European Medicines Agency (EMA), the U.S. Food & Drug Administration (FDA)and Health Canada.

The values of ICH members include:

  • Demonstrating a commitment to high standards for public health;
  • Participating in international harmonisation;
  • Providing an international forum for communication and the building of relationships.

PIC/S

Pharmaceutical Inspection Co-operation Scheme (PIC/S)

PIC/S comprises 49 Participating Authorities coming from all over the world (including Health Canada since 1999).

Its mission is to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practices (GMP) standards and quality systems of inspectorates in the field of medicinal products.

Regulatory Agencies

Pharmascience