As you may know, January 1, 2021, has called off the 11-month long post-Brexit transition period. This also marked the deadline for the United Kingdom (UK) based food and beverages manufacturers to implement their product labeling changes.
- February 5, 2021 Food and Food Supplements, Regulatory Labeling
- February 5, 2021 Chemicals, Regulatory Affairs
Being one of the crucial export sectors of the UK, the Chemicals industry could get hit hard due to Brexit. British companies are already competing with the American and the Asian markets and are under tremendous pressure in battling higher R&D costs.
The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic.
- February 3, 2021 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
During unexpected emergencies, like COVID-19, conducting on-site pharmacovigilance (PV) inspections are not feasible due to travelling difficulties, orders from local authorities, and restrictions to accessing facilities justified by health hazards. Under such conditions, remote inspections would become the most preferable, replacing on-site inspections.
- January 25, 2021 Medical Devices, Regulatory Affairs
Since the onset of Coronavirus Disease 2019 (COVID-19), Health and Human Services (HHS) has declared a Public Health Emergency. The US FDA, since then, has been releasing various enforcement policies to ensure continued supply of certain essential medical devices, which play a vital role in prevention, diagnosis, management and treatment of COVID-19 and associated co-morbidities.
- January 25, 2021 Medical Devices, Regulatory Affairs
The FDA has introduced “Safer Technologies Program for Medical Devices (STeP)” in line with the “Breakthrough Devices Program”, to facilitate timely access to certain devices and device-led combination products.
- January 19, 2021 Regulatory Affairs, Regulatory Medical Writing
Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval.
- January 18, 2021 Cosmetics Regulatory Services, Regulatory Affairs
Due to the growing young population in the country, the cosmetics market of India is proven to be lucrative for manufacturers across the world. The continuous evolution of the industry is driven by the growing awareness of the consumers about their personal care needs, thus, fuelling the demand for local as well as internationally manufactured innovative products.
- January 8, 2021 Chemicals
Chemical mixture importers and downstream users in the EU are obliged to comply with Article 45 to the Classification, Labelling and Packaging (CLP) Regulation if their mixture bears physical or human health-hazardous classification.
- January 5, 2021 Medical Devices, Regulatory Affairs
Medical device industry has been a booming industry with new technologies being introduced from time to time and has been dynamic in terms of Regulatory landscape. The year 2020 has seen a major disruption due to the COVID-19 Pandemic and demanded the Health Agencies to gear up for addressing the pressing situation, thus impacting the Agency’s plan of action.