Pharma GMP News of the Week February 12, 2023

Pharma GMP News of the Week: 12-February-2023

Period: February 5, 2023 to February 11, 2023

Actions of EMA to support the development of medicines for children 

Date of news: February 6, 2023

In the past four years, regulators in the European Union (EU) have undertaken a number of initiatives to improve the effectiveness of paediatric regulatory processes and accelerate the development of paediatric medications. The EMA and European Commission (EC) action plan on paediatrics’ concluding report, which is available in PDF format, highlights these accomplishments.

The paediatric action plan has made some significant advancements, such as:

 i. A stronger emphasis on unmet medical needs.

ii. Adapting legal procedures to better encourage innovation.

iii. Increasing agreement among decision-makers regarding the need for data.


News from EDQM “A High Throughput Sequencing-specific working team is created by the Ph. Eur. Commission”

Date of news: February 9, 2023

The European Pharmacopoeia (Ph. Eur.) Commission resolved to establish a new Working Party on High Throughput Sequencing (HTS) in November 2022. This group will be in charge of developing a general chapter on HTS for the identification of viral extraneous agents. The new general chapter should make it easier to employ this cutting-edge technology, also called as NGS, as a new analytical instrument to guarantee the viral safety of biological treatments. It has a broad virus detection capabilities.

Those with expertise in HTS for the detection of foreign agents in biologicals and in the development and validation of analytical procedures based on HTS (for example, from licencing authorities, official medicines control laboratories, or industry) are invited to apply to join the new Working Party on this crucial journey to improve the safety and efficacy of pharmaceuticals..


FDA Published Final Guidance “Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act”

Date of news: February 9, 2023

This guideline outlines the regulatory and enforcement priorities of the FDA with regard to the outsourcing of the compounding of specific ibuprofen oral suspension products for use in hospitals and health systems. Three viruses—influenza, respiratory syncytial virus (RSV), and coronavirus disease 2019—are currently on the rise in the United States. Young children may develop fever from any of these viruses. The FDA has been informed of an upsurge in demand for products containing ibuprofen oral suspension for treating paediatric fevers. Additionally, the FDA has heard from a number of hospitals and health systems that are having trouble getting these medications to treat fever in children as well as adults who are unable to take solid oral pills.

Additionally, hospitals and health systems have reported difficulties obtaining these medications for use in treating fever in children as well as adults who are unable to swallow solid oral dosage forms (e.g., people with feeding tubes) as a result of, for instance, regional differences in infection rates, resource distribution, or other regional conditions that may change rapidly during the winter months. FDA plans to update, alter, or remove this policy as necessary if the relevant needs and circumstances change. FDA is constantly evaluating the needs and circumstances connected to the temporary policy outlined in this guideline.

Source: Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act 

FDA Published Draft Guidance “Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development”

Date of news: February 10, 2023

This recommendation is intended to provide a framework for debating whether and what kinds of long-term neurologic, sensory, and developmental evaluations might be helpful to support a determination of the safety of a drug, biological product, or device (referred to in this recommendation as a “medical product”) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.

The efficacy or effectiveness of medications whose primary goal is to improve neurologic outcomes, such as neuroprotective drugs, will not be particularly addressed by this guideline. The emphasis of this advice is on long-term assessments of neurodevelopmental safety. Although evaluations of nephrotoxicity, pulmonary toxicity, and toxicity to other tissues and organs may also be required in the development of neonatal medical products, the methodology for those evaluations is outside the purview of this article.


News from EMA “Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9 February 2023 ” 

Date of news: February 10, 2023


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