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In today’s rapidly changing global Regulatory scenario, companies must keep abreast with evolving global label changes to provide accurate and adequate information to the end user in order to safe guard their wellbeing. Given the dynamic nature of global regulations, keeping track of the label changes in real-time and updating the safety data across the global and regional labels in parallel...
The cosmetic products industry of Taiwan always had strict regulations to manage the safety and efficacy of its beauty products. To ensure the supply of safe cosmetics is continued in the country, the Food and Drug Administration (FDA) of Ministry of Health and Welfare of Taiwan has recently modified the regulations for cosmetic products to align with the international standards.
As of...
Life sciences, as an industry, is dynamic in nature due to constant Regulatory enforcement from global health authorities. In such a scenario, as there would be continuous modifications to the safety information that has to be conveyed through drug labels, the label lifecycle management is treated as a mission-critical system. Thus, labeling processes must be streamlined and capable enough to...
The ARPP (the French professional advertising Regulatory authority) has published new recommendations on cosmetic products, which have come into force in France from July 1, 2019. The recommendations are in line with the Technical Document on Cosmetic Claims published by the European Commission (EC) on July 3, 2017. The purpose of the recommendations is to provide guidance on the...
Health Canada (HC) again postpones the mandatory deadline for Drug Master File (DMF) submissions in electronic Common Technical Document (eCTD) format. Referring to the authority’s May 2018 notification, the earlier deadline was Jan 1, 2019 which later got postponed to Sep 01, 2019. Now with the recent notification from the authority, the eCTD format for DMF will be effective from Jan 01, 2020...
In Life Sciences arena, global health authorities always guide and mandate the manufacturers to demonstrate the safety and efficacy of a product through compliant labeling procedures. It is because the labels act as key channels of communication between the product and the end user. Companies must ensure compliance in communicating its safety data right from Core Data Sheet (CDS) to Local...
The European Commission’s (EC) Medical Devices Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) have been the most significant developments for medical device manufacturers willing to enter the European market. These regulations will allow the EU (European Union) regulators to have the required control and oversight of the medical devices entering into the market. The MDR and IVDR...
In recent times, it has been observed that high number of generic drugs are being approved by the United States Food and Drug Administration (US FDA). In parallel, there are also instances of Refuse to Receive (RTR) from the health authority. It might be due to missing or misleading information provided in the Abbreviated New Drug Application (ANDA) Submissions. Though the ANDA applicants are...
Are you a manufacturer of Prescription and Over the Counter (OTC) drugs? Then it is obvious that you are aware of the US Consumer Product Safety Commission (CPSC) regulations under which certain consumer products, including many prescription and OTC drugs are subject to special packaging standards, including Child-Resistant Packaging (CRP) Statements in drug labels. Referring to the same, the...
Though scheduled to take place from March 29, 2019, the Brexit has now postponed to October 31, 2019. The decision is assumed to give more time to the United Kingdom (UK) and the European Union (EU) to agree upon the terms of the UK leaving the EU.
Until now, the EU regulations directly affected the cosmetic products that are distributed in the UK. However, with the Brexit in scenario...
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