The FDA issued a guidance on a temporary policy allowing state-licensed pharmacies and federal facilities that are not registered outsourcing facilities to compound certain drugs for hospitalized patients during the COVID-19 public health emergency. “In light of unprecedented disruptions to, and demands on, the global pharmaceutical supply chain as a result of the COVID-19 pandemic, and in order to respond to evolving regional conditions, additional flexibility is temporarily needed to help ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs used for hospitalized patients with COVID-19,” according to the guidance. Under the temporary policy, the compounded drug must be provided directly to a hospital that is treating COVID-19 patients and that is unable to get adequate supplies of certain FDA-approved drug or drugs compounded at a registered outsourcing facility. The compounded drugs must be labeled with a default by-use-date. State-licensed pharmacies must have state permission before compounding the drugs.
The EMA launched the first phase of its enhanced fast-track monitoring system to help prevent and mitigate supply issues with crucial drugs used for treating patients with COVID-19. In the first phase, each drug company will appoint a single contact point who will report to the EMA and national competent authorities all current and anticipated shortages of drugs in the greatest demand to treat COVID-19 patients in hospital intensive care units, including anesthetics, antibiotics, resuscitation drugs and muscle relaxants. The second phase will broaden the range of COVID-19 treatments subject to the reporting requirements.
The European Commission, EMA and the Heads of Medicines Agencies updated a question-and-answer document on regulatory adaptations to address COVID-19 challenges. For instance, the validity of good manufacturing practice certificates and time-limited manufacturing and import authorizations, as well as the validity of good distribution practice certificates and time-limited wholesale authorizations, will be extended until the end of 2021. Inspections will be carried out remotely, as needed, to support the extensions, with on-site inspections conducted as soon as feasible. The update also discusses adjustments that can be applied to the work of qualified persons, who are responsible for certifying that each drug batch is suitable for release for sale or for use in a clinical trial.
Drugs newly registered in Australia beginning Jan. 1, 2021, must use the Therapeutic Goods Administration’s (TGA) new consumer medicine information (CMI) template. While previously registered drugs must adopt the new format by Dec. 30, 2025, the TGA is encouraging sponsors to use the new format earlier for the benefit of consumers. Developed in response to concerns about the complexity and readability of CMIs, the new template is shorter, better laid out and features a one-page summary that provides the most critical information about a drug at a glance, according to the TGA.