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Is innovation/technology exceeding the legislation of medicinal and cosmetic products?



The only constant thing in the world of medicinal and cosmetic products is the continuous development of innovation and technologies related to them!


Pharmaceutical and cosmetic industries are characterized by high competitiveness and innovation seems to be the vehicle of growth for many of them.


Scientific and technological advancement will drive the transformation of products design and formulation bringing to a meaningful patient or consumer benefits by developing tailored medicinal and cosmetic products that serve the different needs of people around the world. As a result, companies embrace innovation and set this determinant as the foundation to achieve long-term growth and competitive advantage.


The markets of medicinal and cosmetic products keep facing various challenges in particular due to the regulatory requirements from the various agencies at international level, that could lead to a slowdown in the development of new technologies.


On the other hand, policy makers and other stakeholders have become increasingly concerned about the outputs of the pharmaceutical and cosmetic innovation system. Over time, these issues have prompted concern as to whether existing policies can promote the development of major innovations while ensuring sustainable access.





Legislation that supports innovation and progress!








Regulatory authorities play a key role in implementing the measures to enhance alignment and innovation. In order that regulatory systems don’t become dysfunctional and out of step with changes in the technology and science that they regulate, they must assess the best available evidence, and identify policy options to address these challenges.


Given the trend of the developments of technology and innovation, it is often necessary the involvement of stakeholders, including industries, and the continuous collaboration between them and regulatory authorities in order to:

- Improve the capacity to anticipate the challenges represented by new medicinal and cosmetic products, emerging technologies, disruptive innovations that could speed patient/consumer access

- Take into consideration the complexity of the interactions between innovation and legislation

- Assess their potential impact on patient/consumer care, outcomes and society when designing/redesigning regulatory systems for novel products/therapies

- Identify a number of policy options with the potential to address these challenges

- Adapt continuously the legislation related to medicinal and cosmetic products to innovation and technology.


We can expect to see greater collaboration between competent authorities and stakeholders as a result of stakeholders’ engagement to provide input to the authorities’ decision-making as well as greater innovation in new product development.


In the context of supporting the innovation and technology development, regulatory agencies such as FDA, EMA and European medicines regulatory network have taken steps in this direction, among which we can mention:


The Food and Drug Administration Safety and Innovation Act (FDASIA): strengthens the ability of the FDA to safeguard and advance public health by also promoting innovation to speed patient access to safe and effective products.


European Medicines Agency’s Innovation Task Force – ITF: provides a forum for early dialogue with applicants on innovative aspects in medicines development and ensure coordination across the Agency


EU Innovation Network: strengthens collaboration between EMA and national competent authorities on regulatory matters related to emerging therapies and technologies.


All of these initiatives have clear and well-defined objectives that can encourage and facilitate innovation in the field of medicinal products and associated technologies as well as strengthen the engagement between regulators and innovators.


As a conclusion, regulatory authorities must align the regulatory system with the current global trends and industry practices, which will contribute to the sustainable development of the pharmaceutical and cosmetic industry. We need legislation that will encourage innovation in the market, with a clear focus on safety.


All together, by fostering innovation, including in areas of unmet medical needs and adapting to new scientific and technological developments, can begin the next phase of innovation in science and medicine!



References:

1. Anon, Where will new drugs come from? The Lancet 377, 8 January 2011

2. Mittra J, Tait J and Wield D, From maturity to valueadded innovation: lessons from the pharmaceutical and agro-biotechnology industries, Trends in Biotechnology, In press, (doi:10.1016/j.tibtech.2010.11.004)

3. Mittra J, Life Science Innovation and the Restructuring of the Pharmaceutical Sector: Mergers, Acquisitions and Strategic Alliances, Technology Analysis and Strategic Management 19(3): pp279-301, 2007

4. Mittra J, Impact of the Life Sciences on Organisation and Management of R&D in Large Pharmaceutical Firms, Int J Biotechnology 10(5): pp416-440, 2008 5. Tait J, The Pharmaceutical Industry: Bio-engineering a ‘Black Swan’, Britain in 2009, ESRC Publication: p84, 2009 6. Tait et al, Health Biotechnology to 2030, Report to OECD

International Futures Project, The Bioeconomy to 2030: Designing a Policy Agenda, OECD, Paris, p51, 2008, www.oecd.org/dataoecd/12/10/ 40922867.pdf

5. OECD (2018), Pharmaceutical Innovation and Access to Medicines, OECD Health Policy Studies, OECD Publishing, Paris.

6. Comparative Study on Cosmetics Legislation in the EU and Other Principal Markets with Special Attention to so-called Borderline Products. Final Report Contract No.:

FIF.20030624 prepared for European Commission DG Enterprise. Microsoft Word - J457 - FR - CP-QC-TOC.doc (rpaltd.co.uk)

7. Unilever says no to ‘normal’ with new positive beauty vision | Unilever

8. COSMETICS INDUSTRY SELF-REGULATION (harvard.edu)

9. Cosmetics Europe - The Personal Care Association :: Innovation and Future Trends in the Cosmetics Industry

10. New regulations announced! Prepare for rapid cosmetic innovation in China | incosmetics Connect

11. (PDF) Product innovation in cosmetic industry case study of major cosmetic companies (researchgate.net)

12. Sustainable Innovation in the Cosmetic Industry—Obstacles, Contributing Factors, and Strategies A Thesis SUBMITTED TO THE FACULTY OF UNIVERSITY OF MINNESOTA BY Chen Feng

13. Innovation, Regulation, and the FDA | NEJM

14. Innovation in medicines | European Medicines Agency (europa.eu)

15. Food and Drug Administration Safety and Innovation Act (FDASIA) | FDA

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