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Challenges of post-market surveillance activities related to cosmetics: Focus on Cosmetovigilance

Post-marketing surveillance is essential to the effective regulation of cosmetic products, and it is considered a key regulatory function. It refers to the set of surveillance activities that monitor the safety, quality, effectiveness, and use of cosmetic products that are on the market.

Nowadays, the scope of safety surveillance is complex because the safety of a cosmetic product, apart from its properties, is also related to how it is actually used in practice and to the integrity of the quality of the product throughout the supply chain.

All the cosmetic products on the European market must be safe according to the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Despite this, it is possible that undesirable effects can be verified when using them, even though they are usually well-tolerated.

Apart from inspections, quality control testing (physical and laboratory checks) that the national health authorities concentrate their major activities, another important component of the post-marketing surveillance activities, is also the communication/reporting of undesirable effects (UE) and serious undesirable effects (SUE) of cosmetic products (as they are defined on the EU Regulation on cosmetic products).

Cosmetovigilance, as a concept of monitoring the safety of cosmetic products, was first used in literature in 1997 by Vigan. Now it is recognized as an important component of public health activities that addresses the safety of these products. It is the set of activities for the collection and management of reports of undesirable effects attributable to the use of a cosmetic product, carried out with the aim of facilitating post-marketing surveillance and ensuring the protection of final users’ health. However, safety can be achieved when problems that are related to these cosmetic products can be identified and then solved.

According to different reports, undesirable effects of cosmetic products are underestimated and in order that the reporting of UEs/SUEs are not low, it is fundamental that cosmetovigilance systems continue to engage final users and practitioners/health professionals to report suspected UEs and SUEs.

Cosmetovigilance can be improved in practice by increasing the awareness of the National competent authorities reporting system among consumers and professionals. Healthcare professionals should take the responsibility to educate the consumer about the reporting options available, as they have a fundamental role to recognize UEs and SUEs induced by cosmetic products. In this way, an increase in reporting will bring awareness to possible safety issues with specific cosmetic products. As a result, it will encourage the National competent authorities to take all the necessary measures, launch investigations and also review the literature on specific ingredients of cosmetic products.

Apart from common challenges for implementing post-marketing surveillance programs in the legal, financing, human resources, management and planning, sampling and testing methodology areas, extra efforts are needed to strengthen the post-marketing surveillance. It is important to highlight the importance of quality of reports and implementation of a structured vigilance system in order to obtain reliable data and that these activities don’t lack appropriate planning and resources.

Cosmetovigilance systems and the national competent authorities that work with them, must empower their efforts to strengthen the communication with their stakeholders, healthcare practitioners and final users. The nature of these interactions will vary between countries and will depend on their local needs, the structure of the healthcare system, more than the scientific and technical and aspects of the cosmetovigilance. These partnerships must provide expertise, as well as capacity to accomplish relevant monitoring of the safety of cosmetic products.

As a conclusion, a global collaboration to advance the practice of cosmetovigilance in countries around the world would be useful in order to:

- Work nationally but also collaborate internationally;

- Monitor and identify the harm caused by cosmetic products;

- Reduce the risks to final users;

- Establish worldwide cosmetovigilance standards and systems.

This can be done by creating a global database similar to the WHO’s database VigiBase that is used to analyse reports of suspected/potential side effects of medicinal products. The benefit of these reports in a global database is that patterns of harm might emerge from the amount of worldwide data which sometimes might not be evident in the national databases.


1. Guidance for implementing risk-based post-marketing quality surveillance programs in low and middle income countries –

2. Ongoing Challenges in Pharmacovigilance - Gerald J. Dal Pan

3. Buckley GJ, Gostin, Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products; Board on Global Health. Countering the Problem of Falsified and Substandard Drugs. Washington (DC): National Academies Press (US); 2013 May 20.

4. Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli M, de Joncheere CP, Ewen MA, et al. Essential medicines for universal health coverage. Lancet. 2016 Nov 7; 389(10067):403- 76. Accessed: 22 January 2018. Available at:

5. Bill and Melinda Gates Foundation. A report of the safety and surveillance working group. 2013. Accessed: 22 Jan 2018. Available at: 2013_designed.pdf.

6. Promoting the Quality of Medicines (PQM) Program. 2010. Strengthening National Capacity in Medicines Quality: Five-year Summary (2005-2009) Promoting the Quality of Medicines Program in Southeast Asia and the Philippines. Rockville, Md.: The United States Pharmacopeial Convention. Accessed: 22 Jan 2018. Available at:

7. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fiftieth report, WHO Technical Report Series No. 996, Annex 7. 2016. Accessed: 22 Jan 2018. Available at:

8. Kohler J, Mackey T, Ovtcharenko N. Why the MDGs need good governance in pharmaceutical systems to promote global health. BMC Public Health. 2014 14:63. Accessed: 22 Jan 2018. Avaiable at: World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fiftieth report, WHO Technical Report Series No. 996, Annex 7. 2016. Accessed: 22 Jan 2018. Available at:

9. World Health Organization, Expert Committee on Specification of Pharmaceutical Preparation. WHO draft guidance on testing of “suspect” spurious/falsely-labelled/ falsified/counterfeit medicines (QAS/15.634/Rev.2 Draft). 2016. Accessed: 22 Jan 2018. Available at:

10. Pribluda VS, Barojas A, Coignez V, Bradby S, Dijiba Y, et al. The three-level approach: a framework for ensuring medicines quality in limited-resource countries. Pharmaceut Reg Affairs 2014, 3:1 ( Accessed 22 Jan 2018. Available at: 42

11. Ibid.

12. Pisani E. Antimicrobial Resistance: What does medicines quality have to do with it? 2015. Accessed: 22Jan 2018. Available at:

13. Almuzaini T, Choonara I, Sammons H. Substandard and counterfeit medicines: a systematic review of the literature. BMJ. 2013 3(e002923). Accessed: 22 Jan 2018. Available at:

14. Newton PN, Lee SJ, Goodman C, Fernandez F, Yeung S, Phanouvong S. Guidelines for Field Surveys of the Quality of Medicines: A Proposal. PLOS Medicine. 2009 6(3):e1000052. Accessed: 22 Jan 2018. Available at:

15. World Health Organization. WHO Expert Committee on Specifications for Pharmaceutical Preparations, Fiftieth report, WHO Technical Report Series No. 996, Annex 7. 2016. Accessed: 22 Jan 2018. Available at:

16. OMCL Network of the Council of Europe: General Document PA/PH/OMCL (06) 3 9R. European Directorate for the Quality of Medicines and HealthCare: sting_at_omcls.pdf.

17. Fernandez F, Hostetler D, Powell K, Kaur H, Green M. Poor quality drugs: grand challenges in high throughput detection, countrywide sampling, and forensics in developing countries. PMC 2011 Aug 7; 136(15): 3073-82. Accessed: 22 Jan 2018. Available at:

18. Newton PN, Fernandez FM, Plancon A, Mildenhall DC, Green MD. Ziyong L, et al. A collaborative epidemiological investigation into the criminal fake artesunate trade in South East Asia. PLOS Medicine. 2008 Feb 12; 5(2): e32. Accessed: 22 Jan 2018. Available at:

19. World Health Organization. WHO Global Surveillance and Monitoring System for substandard and falsified medical products. 2017 Nov. Accessed: 22 Jan 2018. Available at:

20. World Health Organization. Practical Guidance for Conducting a Review (Regulatory Support Series, No. 12). 2007. Accessed: 22 Jan 2018. Available at: gSys.pdf?ua=1.

21. Potter C, Brough R. Systemic capacity building: a hierarchy of needs. Health Policy Plan. 2004 Sep; 19(5):336-45. Accessed 22 Jan 2018. Available at:

22. Horsch, K. 2006. Indicators: Definition and Use in a Results-Based Accountability System. Cambridge, Ma: Harvard Family Research Project

26. Cosmetovigilance: A review of the current literature

Hale Z. Toklu1 , Abigail Antigua2 , Vanessa Lewis3 , Mar’Tina Reynolds3 , Jennifer Jones1,3 1 Department of Clinical Sciences, University of Central Florida College of Medicine, Orlando, 2 Clinical Pharmacy and 3 Family Medicine, North Florida Regional Medical Center, Gainesville, FL, USA

27. Cosmetovigilance: A review of the current literature - Hale Z. Toklu , Abigail Antigua, Vanessa Lewis, Mar’Tina Reynolds , Jennifer Jones

28. Cosmetovigilance: definition, regulation and use “in practice” - Martine VIGAN, Florence CASTELAIN

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