South Korea has taken a step towards carbon neutrality and has approved the first ever physically recycled Polyethylene Terephthalate (PET) containers for food and beverages.

The new policy, applicable from January 17, 2023, only includes PET containers that have undergone a physical or mechanical recycling process and have not been subject to a chemical recycling process. As per the Promotion of Saving and Recycling of Resources Act (Recycling Act), the South Korean Ministry of Environment (MoE) has graded the packing material into the following four (04) categories:

The United States Food and Drug Administration (US FDA) released guidance in December 2022, a revision of the guidance titled ‘Failure to Response to an ANDA Complete Response Letter (CRL) Within the Regulatory Timeframe Guidance for Industry,’ of July 2022. It is meant to guide the applicants of Abbreviated New Drug Applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). A complete and relevant response to a CRL is crucial for the approval of the generic drug.

China’s pharmaceutical sector is witnessing changes and advancements frequently. In a recent shift, the National Medicinal Products Authority (NMPA) has made electronic certificates for drug registration in China possible. This has been done as an initiative to deepen the reform of the pharmaceutical market and drug supervision. The declaration was given by the NMPA under announcement no. 83-2022, and China has started issuing these e-certificates from November 01, 2022.

In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled ‘Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding.” It is to help sponsors include dose banding information in drug labeling for ready-to-use containers in New Drug Applications (NDAs), Biologics License Applications (BLAs), or supplements to those applications.

In September 2022, the United States Food and Drug Administration (US FDA) released a draft guidance document titled “Statement of Identity and Strength - Content and Format of Labeling for Human Non-prescription Drug Products.” The draft guidance aims to enhance the consistency of labeling for Over-the-Counter (OTC) drugs. It addresses the statement of identity and drug strength for OTC products.

As per the recent update from the Danish Medicines Agency (DMA) dated October 19, 2022, the deadline for submitting marketing authorization and clinical trial applications has been revised to December 20, 2022. The move comes as the DMA will be closed from December 24 to January 01, 2023, for the Holiday Season.

The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL). 

The draft amendment introduces significant changes to the Regulatory framework. It encodes the various Regulatory initiatives undertaken by the Chinese government since the implementation of the current China DAL, which was promulgated in 2019. The Law was intended for data protection and patent linkage.  

According to the CMDh practical guidance for Marketing Authorization Holders (MAHs) of nationally authorized products, the evaluation of nitrosamine impurity or cross-contamination in a marketed product is a critical criterion. Nitrosamines are proven to be carcinogenic and can affect the overall output of the formulated product.

Considering the severity, the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) issued the following first three (03) steps a manufacturer must follow to mitigate the amount of impurity in the final drug product.

Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively. The information submitted to the OPDP and the APLB must be accurate, ethical, and non-misleading. Additional information about the product’s benefits and risks must be included in the submission.

The ever-increasing demand for various channels to share information and engage with customers poses numerous challenges in the pharmaceutical industry. Such engagement comes with risks, particularly in the advertising domain. To ensure accurate and good practice, Health Canada regulates the advertising or promotional material before its dissemination in Canada. The Pharmaceutical Advertising Advisory Board (PAAB) is an organization whose advertising pre-clearance service for healthcare professionals is recognized by Health Canada.