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.

Counterfeit medicine is a major issue all around the world. It is estimated that a significant portion of a pharmaceutical products is counterfeit, and this figure is increasing yearly. Counterfeit drugs endanger the reputation and revenue of legitimate pharmaceutical firms as well as the public's health and safety.

On May 11, 2022, Japan’s Diet passed the ground-breaking “Act on Promotion of Economic Security by Integrated Implementation of Economic Measures” apropos to the government’s policy push reform considering the global unrest and increasing geopolitical risks.

In talks since 2021, the Act was finally approved on May 11, 2022. It is expected to enter into force on or before February 18, 2023.

Overview of the Act

The framework of the Economic Security Law is based on four domains that drive the policy and are as follows:

A comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device, or other product) provides a brief description of the drug substance and the formulation, including the structural formula (if known). An Investigator’s Brochure (IB) is an essential document maintained by a drug developer or investigator throughout the drug development process, and it contains the body of information acquired before and throughout a drug trial. The IB is updated whenever new information about an investigational product becomes available.

Marketing promotions and advertisements in Pharmaceuticals are information of nexus where research concepts are transformed into realistic therapeutic tools, and information is made useful for different sectors in the Health care system. Every year pharmaceutical companies spend a large part of their revenues on promotions and advertising for the successful launch of pharmaceutical products. These promotions and advertising are important sources of public health information that significantly impact consumer choice and behavior.

The Pharmaceuticals and Medical Devices Agency (PMDA) releases Medical Device Safety Communications (MDSCs) to convey important safety information to patients and healthcare professionals. PMDA releases different types of safety communications, such as:

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.

A drug therapy regimen is diverse for drugs that can be approved to be used in combination with a previously approved drug or simultaneously developed two novel drugs, that synergistically enhance efficacy. Single-drug cancer therapies significantly showcased drug resistance as a major threat for patients undergoing treatments with anti-cancer drugs. Considering the diversity in combination therapy adopted for cancer treatments, two-drug regimens are gradually replacing monotherapy as a standard of care in patients.

DYK? The National Medical Products Administration (NMPA), along with China National Intellectual Property Administration (CNIPA), has released “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)." It is a patent registration platform for chemical drugs, biological products, and traditional Chinese medicines. Along with this, the measures will also help by offering opportunities for market approval based on registered patents and judgment outcomes for chemical entities.