Supply chain challenges across the globe have laid bare the inefficiencies of the distribution system framework amidst the pandemic. Considering its enduring impact on the global pharmaceutical market, better operational structure and resilient operational framework are the basis for seamless manufacturing requirements in hindsight.
- December 15, 2021 Pharmaceuticals, Registration Strategy, Market Access
- December 15, 2021 Pharmaceuticals, Regulatory Affairs, Regulatory Consulting
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.
- December 10, 2021 Medical Devices
With the development of technological advancements, there is an increase in the usage of network connection technology for medical devices. The connected medical devices store and transmit the patient data and demand both privacy and accuracy. Therefore, the cybersecurity of medical devices will continue to be in focus for regulators and manufacturers.
- December 10, 2021 Pharmaceuticals, Regulatory Affairs, Health Authority Updates
The Therapeutic Goods Administration (TGA) has recently modified the registration process for prescription medicines and biologicals. The changes are applicable to new medicines, extended uses, and new combinations. Once approved, the drugs enter into the Australian Register of Therapeutic Goods (ARTG) and are available to people upon prescription by physicians.
- December 10, 2021 Pharmaceuticals, Regulatory Affairs, Health Authority Updates
The Therapeutic Goods Administration (TGA) in Australia has stringent rules for registering new prescription medicines with novel active ingredients. Recently, the TGA has come up with a revised process to improve the efficacy of life-saving prescription drugs and make them available to patients faster.
- December 9, 2021 Chemicals
With the dynamic landscape and the new reality due to the pandemic, the chemical industry has undergone a huge shift in demand. In the chemical market, the end of life for certain materials can start something new. Implementing a series of targeted, strategic initiatives across major functional areas can help manufacturers cater to short term demands.
- December 9, 2021 Pharmaceuticals, Regulatory Labeling
Drug labeling and package leaflets play an important role for both patients and healthcare professionals in the safe and efficient use of the medication. Hence, the approval of the labeling content, Patient Information Leaflet (PIL), and Summary of Product Characteristics (SPC) are integral components of the marketing authorization process.
- December 3, 2021 Food and Food Supplements, Regulatory Affairs, Regulatory Labeling
Any food product or ingredient, such as nuts, seafood, peanuts, gluten-containing cereal, latex, penicillin, etc., can pose allergies when ingested into a human body. According to research, generally, food allergies affect 2.5% of the general population.
- December 3, 2021 Cosmetics Regulatory Services, Regulatory Affairs
Fragrances are a combination of chemicals that render a pleasant scent to perfumes and colognes. Cosmetics and personal care products like makeup products, moisturizers, and shampoos contain fragrances. An attractive fragrance makes the product more appealing to the consumer and enhances the user experience. Fragrances also influence buying behavior and give a competitive edge to the product.
- November 29, 2021 Medical Devices
With the evolution of technology, the healthcare industry has become keen on integrating software with medical devices to incorporate automation and accuracy in the prediction, diagnosis, prevention, treatment, and management of health conditions.