Numeral 11 — NOM-073-SSA1-2015, Estabilidad de fármacos y medicamentos (modifica a la NOM-073-SSA1-1993, Estabilidad de medicamentos, publicada el 3 de agosto de 1996).

11 Concordancia con normas internacionales

Esta Norma es parcialmente equivalente a los estándares internacionales:

11.1 European Medicines Agency, Committee for medicinal products for human use & Committee for. medicinal products for veterinary use. Guideline on quality of herbal medicinal products/traditional herbal

medicinal products, 2006.

11.2 International Conference o n Harmonisation of Technical Requirements for Registration of. Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1A (R2): Stability Testing of New Drug

Substances and Products (Feb. 2003).

11.3 Food and Drug Administration, Center for Drug Evaluation and Research Guidance for Industry:. Stability Testing of Drug Substances and Drug Products (Draft, June 1998).

11.4 International Conference on Harmonisation of Technical Requirements for Registration of. Pharmaceuticals for Human Use ICH Harmoni sed Tripartite Guideline Q1C: Stability Testing for New Dosage

Forms (Nov. 1996).

11.5 International Conference on Harmonisation of Technical Requirements for Registration of. Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1D: Bracketing and Matrixing Designs

for Stability Testing of Drug Substances and Drug Products (Feb. 2002).

11.6 International Conference on Harmonisation of Technical Requirements for Registration of. Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline 5C : Quality of Biotechnological

Products: Stability Testing of Biotechnological/Biological Products.