The beauty and personal care industry is constantly evolving, driven by the pursuit of newer innovations and trends. With an array of cosmetic products flooding the market, it is crucial to prioritize consumer safety. In the European Union (EU), cosmetic safety assessment plays a pivotal role in ensuring that all products entering the market meet stringent safety standards before reaching consumers.
As per the European Union (EU) regulations, any cosmetic product that is to be sold within the EU must have a designated Responsible Person (RP) who is responsible for ensuring that the product complies with all the applicable regulations. The RP must be located within the EU and must possess enough technical knowledge about the product in question. Companies that do not have an EU presence must appoint a third-party RP to fulfil this obligation.
Are high-interest rates, rising inflation, and unpredictable economic climate influencing your organization’s downturn? According to one of the reports, the medical science industry will necessitate seventy thousand (70,000) Regulatory roles over the next decade. Filling these positions has been and will continue to be a challenge for the industry.
So, what must pharmaceutical companies do to compete in today’s fast-paced and dynamic economic environment to fill in the gaps successfully?
The process of submitting Regulatory documentation to Health Authorities can be complex and time-consuming. Many organizations partner with a vendor that offers a submission tool to ease this process. With so many options in the market, it can be difficult to know who the right strategic partner is for your submission requirements.
To ensure that cosmetics align with the latest quality and safety standards, markets across the globe have stringent Regulatory requirements. In markets such as the European Union, the United Kingdom, Malaysia, India, Saudi Arabia, etc., appointing a Legal Representative/Responsible Person (RP)/ Local Agent/License Holder is mandatory for local compliance. Due to the economic and operational constraints, establishing own subsidiaries in each country may not be feasible for all cosmetic manufacturers. Hence, manufacturers must appoint a Responsible Person for a seamless market entry.
Applicants often misunderstand the scope of the meetings with the Medicines and Healthcare products Regulatory Agency (MHRA) and fail to comply with the legislative requirements of such meetings. These misunderstandings create prejudice against the procedure and affect the success rate of the meetings.
Scientific advice meetings with the MHRA can be held in the following phases.
The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
Mexican Medical Device market is expected to reach $6.5 billion by 2020. Being the second largest market for medical devices in Latin America, Mexico offers a good bet of business opportunities. However, to market the devices in the region, manufacturers need to follow certain standards and procedures and should perform a clear-cut mapping of organizational goals and capabilities with that of Mexico’s regional Regulatory requirements.
The Life Sciences market is growing and is expected to reach US$ 4,200 Million by the end of 2024. At the same time, the world is turning more protective about increasing health concerns. Alongside addressing the health needs and aligning with the market scenario, the pharma, biotech, cosmetic, medical devices and healthcare organizations shouldn’t only innovate new compliant products, but also ensure that they are accessible across the globe with stringent safety and efficacy measures.
The upsurge of economic and industrial developments across the Middle East and North Africa has established the MENA region as a dynamic life sciences and healthcare market. As per reports, consistently growing affluence in the Gulf Cooperation Council (GCC) countries has led to many lifestyle changes resulting in steep rise in total healthcare expenditures. That suggest growing importance for healthcare that could in turn drive the region’s pharmaceutical sales.