Global regulators to meet on safety of drug container labels

A global summit on drug container labeling and packaging safety is planned June 19 and 20, 2018 on the FDA campus in White Oak (Silver Spring) MD. The meeting is being cosponsored by the US Food and Drug Administration (FDA) and the International Medication Safety Network (IMSN).

The World Health Organization (WHO) will also attend. Reduction of medication errors is a main theme of the World Health Organization's (WHO) Global Patient Safety Challenge: Medication Without Harm. The meeting is open to regulators, FDA staff, IMSN members and invited speakers only. More information can be found here.

To achieve a reduction of overall harm related to medication errors, harmonization at the global level is desirable. Many of the product container labeling, and packaging issues are common across countries. Also, in many countries and regions throughout the world, domestic drug manufacturing does not exist and it is common for drugs to be imported, often with features that can result in safety issues. Dangerous situations are also experienced when drug shortages lead to temporary importation of products, some of which exhibit unfamiliar characteristics that may raise safety issues here.

To maximize safety, it would be beneficial to identify safety issues, and harmonize labeling requirements as much as possible with a focus on reducing medication errors. Some regulators have already undertaken such efforts, and have met with some success in reducing medication errors related to approved labeling. This meeting will provide an opportunity to share experiences and discuss ways to improve medication safety globally.

Participating regulators include:

Anvisa (Brasil)
European Medicines Agency (EMA – European Union)
Ghana Food and Drug Administration
Health Canada
INFARMED (Portugal)
INVIMA (Colombia)
Medicines Evaluation Board of Netherlands
MHRA Medicines & Healthcare products Regulatory Agency (United Kingdom)
Saudi Food and Drug Authority
United States Food and Drug Administration