Pharma GMP News of the Week: 20-November-2022

Period: November 13, 2022 to November 19, 2022

The Indian government has revised the Drugs (Prices Control) Order, 2013 to reflect the publication of the National List of Essential Medicines (NLEM) 2022.

Date of news: November 2022

Indian officials announced the amended NLEM in September, eliminating 26 medications and adding 34 more to produce a list of 384 recognised items deemed necessary by the government. The list contains additional cancer medications, newer diabetic treatments, and four patent-protected drugs, and it explains the reach of Indian pricing limitations.

The amended legislation includes the NLEM drugs, as well as the level of healthcare in which they are utilised — primary, secondary, or tertiary — and the dosage form and strengths covered by the price control order. Companies that reformulate NLEM components to improve on the basic product will face various rules.

Source: https://pharmaceuticals.gov.in/sites/default/files/Drugs%20Prices%20Control%20Amendment%20Order%202022.pdf 

News from India, NPPA, India – In response to input from stakeholders on operational difficulties, India’s National Pharmaceutical Pricing Authority (NPPA) modified the Integrated Public Database Management System 2.0 (IPDMS). 

Date of news: November 14, 2022

The NPPA met with stakeholders last month to discuss the rollout of IPDMS 2.0, the system used to gather data from pharmaceutical manufacturers online, and to get their opinions on the operational challenges the sector is now facing. The conference produced 40 problems, which the NPPA listed and addressed in a fresh report of the conversation.

Source: https://www.nppaindia.nic.in/wp-content/uploads/2022/11/IPDMS-Ver-2.pdf 

Notice from MHRA on “Access Consortium Good Manufacturing Practice (GMP) Statement”

Date of news: November 15, 2022

Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition.

Source: Access Consortium Good Manufacturing Practice (GMP) Statement – GOV.UK

News from EDQM – “Polypharmacy and ageing” – EDQM participation in ESCP symposium in Prague

Date of news: November 15, 2022

The 50th European Society of Clinical Pharmacy (ESCP) Symposium, with the theme “Polypharmacy and ageing – customised, person-centered treatment,” was held in Prague from October 19 to October 21, 2022. EDQM representatives attended.

Source: https://www.edqm.eu/en/-/-polypharmacy-and-ageing-edqm-participation-in-escp-symposium-in-prague 

New from MHRA “MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use”

Date of news: November 16, 2022

The MHRA has received inquiries from a number of businesses about cannabis-based medicines. This blog offers details on the authorizations needed to manufacture in this area of the pharmaceutical business, according to MHRA Manufacturing Licence Application.

Please refer to the following guideline, which was revised in March 2020, for an overview of unlicensed cannabis-based products for medical use (unlicensed CBPMs).

Source: MHRA Process for approving Manufacturing Authorisations or API Registrations in relation to unlicensed Cannabis-Based Products for Medicinal Use

Update on MHRA site on “Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing”

Date of news: November 17, 2022

Source: Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing – GOV.UK 

PIC/S published Concept Paper on the revision of EU-PIC/S GMP Annex 11 (Computerised Systems)

Date of news: November 17, 2022

A concept paper on the revision of Annex 11 (computerised systems) of the EU-PIC/S GMP Guide has been created by a dedicated European Medicines Agency (EMA) Drafting Group, in which PIC/S is represented by Ib Alstrup (Denmark / DKMA), who is also the Chair of the PIC/S Working Group on the revision of PI 011 (PIC/S Recommendation on Computerized Systems).

This concept paper is available for download on the PIC/S website (https://picscheme.org/en/publications?tri=date#zone) as well as the EMA website (https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/gmp-gdp-inspectors-working-group#concept-papers,-reflection-papers

By January 16th, 2023, comments must be submitted to ADM-GMDP@ema.europa.eu using the EMA template, which may be downloaded using the link in the Concept Paper.

Source: https://picscheme.org/docview/4967 

FDA published “Cybersecurity Modernization Action Plan” on its website

Date of news: November 17, 2022

A new action plan for tackling cybersecurity has been announced by the US Food and Drug Administration (FDA), stating the agency’s aim to improve, modernise, and upgrade its defences against assets and data.

The Office of Digital Transformation (ODT) takes its duty to protect people and data in today’s climate of rising cybersecurity threats seriously. Cybersecurity is one of the FDA’s top priorities. We have created this Cybersecurity Modernization Action Plan (CMAP) in order to improve situational awareness, modernise cybersecurity capabilities, and strengthen the FDA’s ability to protect sensitive information in order to reduce overall security risks to the Agency. We are aware of the dangers that come with running a global information technology enterprise.

Source: Cybersecurity Modernization Action Plan | FDA

FDA published final guideline on “Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act”

Date of news: November 18, 2022

Regarding the production of beta-lactam oral antibiotic suspension products that are included on the FDA’s medication shortage list by a licensed pharmacist in a State-licensed pharmacy or Federal facility, this guideline outlines the FDA’s regulatory and enforcement priorities. There is a severe lack of amoxicillin oral antibiotic powder for suspension right now. Products made of the oral antibiotic amoxicillin powder for suspension are now listed as being in low supply by the FDA. 

Amoxicillin is frequently used, among other things, to treat bacterial upper and lower respiratory infections in children. There is an urgent need to boost the availability of these beta-lactam oral suspension solutions as a result of this scarcity. Numerous reports on the rising demand for amoxicillin oral antibiotic suspension products in particular have been sent to FDA. Concerning the creation of compounded versions of those products from FDA-approved tablets and capsules, FDA has also received requests for clarification.

Source: Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act | FDA

EMA published article on “European Antibiotic Awareness Day 2022: Preventing antimicrobial resistance together”

Date of news: November 18, 2022

EMA is emphasizing on criticality to raise awareness of the threat that antimicrobial resistance poses to global public health and to act immediately. To read more about it, refer to the following link.

Source: https://www.ema.europa.eu/en/news/european-antibiotic-awareness-day-2022-preventing-antimicrobial-resistance-together

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