March 1, 2022 Regulatory Updates

Pharma-Regulatory Updates Roundup Feb 2022


Human medicines: highlights of 2021

In 2021, EMA recommended 92 medicines for marketing authorisation. Of these, 53 had a new active substance which had never been authorised in the European Union (EU) before. This is a 35% increase compared to the 39 medicines with a new active substance that were authorised in 2020.

Once a medicine is authorised by the European Commission and prescribed to patients, EMA and the EU Member States continuously monitor its quality and benefit-risk balance and take regulatory action when needed. Measures can include a change to the product information, the suspension or withdrawal of a medicine, or a recall of a limited number of batches.

An overview of some of the most notable recommendations, including safety recommendations for COVID-19 vaccines that received global public attention, is also included in the document.


New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) provides clarity to drug developers on the necessary study design elements and other data needed in the drug application to support a full and comprehensive assessment.

To do so, CDER relies on its understanding of the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat.

ROW Market Countries Updates


Submission dates for 150-days assessment procedure for national marketing authorisation applications containing new active substances

The MHRA will operate a 150-day Assessment route for high-quality marketing authorisation applications (MAAs).

For applications containing new active substances, submissions should be received by the following dates in order to align with the meeting dates of the Commission on Human Medicines (CHM).

The Marketing authorisation application dossier should be submitted through the MHRA Submissions portal


Relaunch of the scientific publication of ANMAT

“ANMAT Scientific Magazine” will seek to generate content that promotes advances in the regulatory field. The relaunch is not limited to a new name, but rather aims to enhance the quality of its scientific-technical content, promote the publication of excellent original articles prepared by the various areas of ANMAT and invite external researchers and institutions to carry out their research. In fields related to the ANMAT, to be part of the issues that are published.

These changes, which will be reflected in the successive editions, will bring innovations in graphic aspects and in the management for the evaluation of articles, as well as greater diffusion at a national and international level.


Anvisa adopts new regulatory model

Anvisa’s new regulatory model came into effect on April 1st, 2019, aiming at improving and qualifying Brazilian sanitary standards. The measure changes the construction and review of normative acts and simplifies internal work processes. It also stimulates the presentation of technical evidence for the elaboration of rules, with greater value given to the use of mechanisms of social participation.

The measure is focused on strengthening the Regulatory Impact Analysis (RIA), a methodology that allows for the evaluation and initial studies of regulations, so to provide qualified subsidies for the decision of the Board of Directors (Dicol).


SAHPRA and USP announce MOU to advance regulatory oversight medical products in South Africa

The South African Health Products Regulatory Authority (SAHPRA) has signed a Memorandum of Understanding (MOU) with the U.S. Pharmacopeia (USP) to help expand the availability of health products, including medical devices. That are safe, efficacious, and of assured quality.
To this end, SAHPRA and USP will collaborate to:

  • Strengthen capacity for the adoption of risk-based approaches for regulatory inspections and post-marketing surveillance.
  • Strengthen quality control laboratories for medicines, biologicals, and vaccines as well as medical devices
  • Collaborate on advancing regional regulatory harmonization initiatives of strategic importance for SAHPRA and USP
  • Contribute to improving public health in Africa by promoting timely access to quality-assured health products and advancing innovation

QATAR (Ministry of Public Health)

MOPH issues clarification on pharmaceutical products containing metformin

Ministry of Public Health (MOPH) has indicated that the results of laboratory analysis conducted on samples of all pharmaceutical preparations containing metformin available in the public and private sectors in the State of Qatar have proven to be safe and free from the N-Nitrosodimethylamine (NDMA).formulation of the “Guidelines for the Registration and Review of Drug-device Combination Products Based on the Role of Medical Devices” and “Guidelines for the Registration and Review of Drug Qualitative Quantitative and In vitro Release Research in Drug-device Combination Products Based on the Role of Medical Devices”, which are hereby released.

It is noteworthy that Metformin is a drug used to treat diabetes and its trade name is registered as Glucophage, while NDMA is present in nature but in small and safe proportions.


Description of changes made to the revised compendium of guidelines for marketing authorization of medicinal products

The Compendium of Guidelines for Marketing Authorization of Medicinal Products was developed following the review of existing guidelines for registration of human medicines with the aim of updating the requirements in line with international best practices and addressing various challenges presented by out stakeholders.

The Compendium of Guidelines incorporate new templates, additional information requirements for product labels, minor updates to existing guidelines as well as introduction to two new documents that is Quality Information Summary (QIS) template and Guidelines on Naming of Medicinal Products. Additionally, three new terminologies, “extension applications”, “duplication license” and “unique identifier” have been induced.

UKRAINE (State Service of Ukraine)

Products manufacture conditions to the GMP requirements came into force

The order of the Ministry of Health of Ukraine as of 09.06.2020 № 1346 registered by the Ministry of Justice of Ukraine on 03.07.2020 № 616/34899 approves changes to the Order on conducting confirmation of compliance of the medicinal products manufacture conditions with good manufacture practice requirements that was approved by the order of the Ministry of Health of Ukraine as of 27.12.2012 № 1130 and registered by the Ministry of Justice of Ukraine of 21.01.2013 № 133/22665 (order of the Ministry of Health of Ukraine as of 22 July 2015 № 452 with changes). Order of the Ministry of Health of Ukraine as of 09.06.2020 № 1346 came into force on 21.07.2020 (Official Bulletin of Ukraine № 56).

Subsequent to the trails, the Expedited Approval Scheme for Class II/III/IV General Medical Device Listing Applications will continue on a regular basis. Details of the said Scheme are given in the application form MD-C2&3&4 2022 Edition.

MALAYSIA (Ministry of Health Malaysia)

Efavirenz (including combination products): Risk of late onset neurotoxicity

Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in the combination treatment of human immunodeficiency virus (HIV-1).Currently, there are 11 products containing efavirenz (including combination products) registered in Malaysia, all of which are in oral formulations.

  • The National Pharmaceutical Regulatory Agency (NPRA) has received information from the registration holder of efavirenz products regarding the risk of late onset neurotoxicity associated with efavirenz use.
  • Efavirenz is mainly metabolised by the cytochrome P450 system (e.g. isozymes CYP2B6) in the liver.1-3 Efavirenz toxicities occur more commonly in patients with CYP2B6 slow metaboliser genotypes, such as black African genetic ancestry which are associated with increased efavirenz levels.

Based on all available evidence reviewed from signal detection from adverse event reports and literature studies, Swissmedic has requested the registration holders of efavirenz products to update package insert with this safety information.

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