Recently, Per the revised Manual of Policies and Procedures (MAPP) of the United States Food and Drug Administration (USFDA) has proposed new labeling rules under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (FD & C Act). This Section covers the FDA’s approval of an Abbreviated New Drug application (ANDA) even after a few changes in the labeling for the Reference Listed Drug (RLD).
- November 9, 2021 Pharmaceuticals, Regulatory Labeling
- November 8, 2021 Pharmaceuticals, Regulatory Affairs
After the initial discovery of nitrosamine impurities in drugs and Active Pharmaceutical Ingredients (APIs) by the USFDA in mid-2018, the EU Regulatory bodies have also joined many other countries in a bid to prevent the risks involved. They have re-called several medicines that post health perils from the substance.
- November 3, 2021 Pharmacovigilance, Pharmaceuticals
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit organization that strives to maintain an updated database to summon Regulatory Agencies and pharmaceutical manufacturers to discuss scientific and technical aspects of the industry on a single platform.
- November 3, 2021 Biologicals, Regulatory Affairs
Biologicals are booming as therapy and have significantly become an established treatment option to provide ailment to niche disease segments which seemed impossible earlier. COVID-19 pandemic has made researchers keen to develop biosimilar and interchangeable products for the patient population at an affordable price.
- October 26, 2021 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
China has established its position as a manufacturing hub for pharmaceuticals. Innovation in manufacturing techniques has encouraged China to explore the scope of research and development for medicinal preparations. The National Medical Products Association (NMPA) looks after the safety of drugs, medical devices, and biologics along with their regulation by undertaking their standards’ management.
- October 12, 2021 Cosmetics Regulatory Services, Regulatory Affairs
The use of red/brown- and green-colored dots to classify vegetarian or non-vegetarian is a mandated practice for food products in India. These dots are labeled on the food products’ packaging. However, there is no such system for cosmetics in India that declares their vegetarian or non-vegetarian nature.
- October 6, 2021 Food and Food Supplements, Regulatory Affairs
The Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 was implemented on January 1, 2018.
- September 24, 2021 Medical Devices, Regulatory Affairs
Medical device Post Marketing Surveillance (PMS), an important practice in the entire pharmacovigilance activity, is the process of ensuring the continued safety and efficacy of the device after it is approved and marketed. When the medical device is launched in the market, it is used by a large number of the general population with various medical conditions.
- September 24, 2021 Medical Devices, Regulatory Affairs
Therapeutic Goods Administration (TGA), under the ‘Therapeutic Goods Act 1989,’ is entitled to regulate medical devices placed and marketed in Australia. Medical devices are regulated under the Therapeutic Goods (Medical Devices) Regulations, 2002. Initially introduced in 2002, the regulations underwent multiple amendments at a frequency of at least once a year, almost every year.
- September 20, 2021 Medical Devices, Regulatory Affairs
The medical devices market in Mexico is growing significantly and is expected to reach USD 7.6 billion by 2025. It is considered a tough market in terms of medical device regulations. The Federal Commission regulates medical devices in Mexico for the Protection against Sanitary Risk, i.e., COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).