Pharma GMP News of the Week: 7-November-2021

Period: October 31, 2021 to November 06, 2021

FDA published draft guideline on “Content of Premarket Submissions for Device Software Functions”

Document issued on: November 4, 2021

On November 4, 2021, FDA issues the guidance on “Content of Premarket Submissions for Device Software Functions”. The guideline outlining FDA thinking on the documentation needed to support the agency’s assessment of device software functions for premarket submissions. This draft guidance document is being distributed for comment purposes only.

According to the guideline, it is intended to cover: 

• firmware and other means for software-based control of medical devices; 

• stand-alone software applications;

• software intended to be operated on general-purpose computing platforms; 

• dedicated hardware/software medical devices; and 

• accessories to medical devices when those accessories contain or are composed of software. 

FDA also provided clarity in terminologies used under this guideline. 

As per the guideline “FDA refers to a software function that meets the definition of a device as a “device software function.” For example, a device software function may control a hardware device or be part of a hardware device (i.e., Software in a Medical Device, or SiMD) or be a device without being part of a hardware device (i.e., Software as a Medical Device, or SaMD).”

As per the FDA “the term “function” is a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. For example, a product with an intended use to analyze data has one function: analysis”.

Source: FDA.gov

Link to the Guideline Document: https://www.fda.gov/media/153781/download

Federal Register notice: https://www.govinfo.gov/content/pkg/FR-2021-11-04/pdf/2021-24061.pdf

US Food and Drug Administration (FDA) has released the commitment letter of the Generic Drug User Fee Amendments (GDUFA III) program (For fiscal years 2023-2027)

News of the month: November 2021

As per the FDA, “this document contains the performance goals and program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, known as GDUFA III.  It is commonly referred to as the “Goals Letter” or “Commitment Letter.”  The Goals Letter represents the product of the Food and Drug Administration’s (FDA or the Agency) discussions with the regulated industry and public stakeholders, as mandated by Congress.  The performance goals and program enhancements specified in this letter apply to aspects of the generic drug assessment program and build on the GDUFA program established and enhanced through previous authorizations”.

As per the letter, “New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles for abbreviated new drug applications (ANDAs) and facilitate timely access to quality, affordable, safe and effective generic medicines.  Certain new enhancements are specifically designed to foster the development, assessment, and approval of Complex Generic Products”.

Source: fda.gov

Download:

https://www.fda.gov/media/153631/download

https://www.fda.gov/media/101052/download

India has issued Draft Policy to Catalyze Research & Development and Innovation in the Pharma – MedTech Sector.

Circular dated: October 25, 2021

Timeline for comments submission declared: November 2, 2021

As per the draft policy “this “Policy to Catalyze R&D and Innovation in the Pharma- MedTech Sector in India” is a commitment to encourage Research & Development (R&D) in pharmaceuticals and medical devices and to create an ecosystem for innovation in the sector in order for India to become a leader in drug discovery and innovative medical devices through incubating an entrepreneurial environment. It acknowledges the need for greater emphasis on encouraging R&D, through indigenously developed cutting-edge products and technologies across the value chain”.

Source: https://pharmaceuticals.gov.in/important-document/regarding-draft-policy-catalyze-research-development-and-innovation-pharma

Download:

https://pharmaceuticals.gov.in/sites/default/files/Draft%20Policy.pdf

https://pharmaceuticals.gov.in/sites/default/files/R%20%26%20D%20PPT.pdf

TGA release update on GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic.

Date of update: November 01, 2021

In this update, TGA has provided an update on certain temporary measures introduced last year for overseas manufacturers.

It includes details regarding:

• On-going use of Remote Inspections

• GMP Clearance

• Mutual Recognition Agreement (MRA) pathway

• Fees

Source: https://www.tga.gov.au/gmp-approach-overseas-manufacturers-medicines-and-biologicals-during-covid-19-pandemic

EMA encourages companies to submit type I variations for 2021 in November 2021

News released on: October 29, 2021

According to EMA news, “the European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2021 no later than Tuesday 30 November 2021. This will enable EMA to acknowledge the validity of the submissions before the Agency’s closure between 23 December 2021 and 3 January 2022 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008”.

Further to this, agency is advising that “Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3 December 2021 for a start of procedure in 2021. For submissions received on or after 6 December 2021, the procedure may not start until January 2022”.

Source: https://www.ema.europa.eu/en/news/regulatory-update-ema-encourages-companies-submit-type-i-variations-2021-november-2021

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