Meras Consulting https://meras-consulting.com Mon, 01 Feb 2021 17:19:09 +0000 en-US hourly 1 https://wordpress.org/?v=5.6.13 Covid -19 and the Regulatory Environment in the Middle East and Africa Countries https://meras-consulting.com/covid-19-and-the-regulatory-environment-in-the-middle-east-and-africa-countries/ Mon, 25 Jan 2021 15:51:42 +0000 https://meras-consulting.com/?p=4758 As a result of the COVID-19 Pandemic situations, many of the Middle East and Africa countries has taken different measures and issued related regulations to cope with this difficult situation. In this article, we will go through the Covid -19 and regulatory environment in various countries and discuss some outlines regarding the current situation. Bahrain […]

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As a result of the COVID-19 Pandemic situations, many of the Middle East and Africa countries has taken different measures and issued related regulations to cope with this difficult situation.

In this article, we will go through the Covid -19 and regulatory environment in various countries and discuss some outlines regarding the current situation.

Bahrain

  • The National Health Regulatory Authority announces (NHRA) offering all its services electronically starting from Sunday 22nd March 2020 until further notice. All appointments have been postponed as well.
  • All are requested to submit any request/letter /document through email only to the concerned staff as mentioned in (Annex 1), no hard copies will be accepted in PPR reception except for the IRF responses with CD’s and Baseline.

Kenya

PPB/REG/GEN/VOL.11/O12/20: Requirements for Emergency Use Authorisation of COVID-19 Rapid Test Kits, 20-Apr-2020

Board established a procedure as a guide to all persons intending to place on the market any COVID-19 health product and health technology, more specifically medical devices and IVDs.

The Pharmacy and Poisons Board (PPB) has instituted internationally accepted Emergency use/ Compassionate use Authorisation (EUCUA procedure), for quick authorisation of treatments and diagnostics to combat the effects of Covid-19 disease. Approval timelines shall be determined on a case by case basis and maybe as short as in a matter of an hour or few hours

Good Manufacturing Practices (GMP). Due to travel restrictions attributed in part to COVID-19, PPB will carry out continued re-certification of manufacturing sites using internationally accepted off-site inspection criteria while making sure that good practice standards are being adhered to. The validity of expiring GMP certificates will be extended for 12 months upon payment of applicable fees and as long as the manufacturing site meets the minimum requirements based on risk-based criteria defined by PPB and in line with international standards. Some of the innovative and risk-based approaches that will be used include but not limited to; off-site inspection (desk-top review), cGMP recertification based on reliance on other MRA reports and/or certification, possibility of batch-to-batch PPB clearance based on specified documents and controls.

PV Inspection: Under crisis situations (e.g. pandemic), on-site inspections may not be possible due to multiple factors. Under such circumstances, the inspectorate, when applicable, should decide on a case by case basis whether a remote inspection will prove sufficient to gain an adequate overview of the functioning of the MAH’s PhV system. Otherwise a postponement of the on-site inspection should be considered. Remote inspections should follow the guidelines and procedures that already exist for coordinating, preparing and conducting PhV inspections, but should take into consideration the limitations imposed by using a remote process.

Tunisia

In the context of the world health crisis related to Covid-19 pandemic, the Directorate of Pharmacy and Medicine (DPM):

  • Informed importers of drugs and medical products on the exceptional measures put in place and applicable to products subject to technical control upon importation.
  • Published additional requirements for the importation of products submitted to the Directorate’s Technical Control Upon Importation.
  • Issued a new procedure for marketing authorization application submission as of 06-Oct-2020, for a better assessment management of the dossiers submitted online.
  • Set up new rules to be followed by importers when submitting importation dossiers of products subject to technical control upon importation
  • Invited companies to use its electronic channels of communication for all services that do not need physical presence, between 8 am and 2.30 pm:

Lebanon

  • Barcoding regulations extended to end of 2020
  • In the context of Covid-19 pandemic, the Lebanese Ministry of Public Health decided to allow the submission of importation invoices in scanned copies and with e-signature for the following products
  •  

Saudi Arabia

Saudi_Food_Drug_Authority

  • Saudi Food and Drug Authority (SFDA) enhanced its online communication channels with companies, instead of face-to-face meetings: Skype, telephone, Whatsapp. Covid-19 – Online Communication Channels provides both Data Matrix codes and telephone numbers that can be used either to setup a Skype meeting or to contact the SFDA reviewers
  • Extension of drugs shelf-life in order to ensure the availability of the products on the market.
  • Saudi FDA Regulatory requirements for Emergency Use Authorization (EUA) for IVDD and Personal Protective Equipment (PPE) during the outbreak of COVID-19:
  1. Expedite the Approval Process for Personal Protective Equipment (PPE).
  2. SFDA Regulatory requirements for the approval of COVID-19 test Kits and PPE
  3. List of SFDA emergency authorization (EUA) and Medical Devices Marketing Authorization (MDMA) for COVID-19.
  4. Strengthening the proactive and reactive activities of Post-market surveillance

Algeria

Algeria

Executive Decree No.20-109: Exceptional Measures to Facilitate the Supply of the National Market in Pharmaceutical Products, Medical Devices and Detection Equipments For the Fight Against Covid-19 With Exceptional Facilitating Measures was published on the Journal Official No. 27 of May 6, 2020.

Executive Decree No.20-109: Exceptional Measures to Facilitate the Supply of the National Market in Pharmaceutical Products, Medical Devices and Detection Equipments For the Fight Against Covid-19 With Exceptional Facilitating Measures was published on the Journal Official No. 27 of May 6, 2020.

The Algerian Ministry of Health published the list of pharmaceutical products, medical devices and detection equipment intended for the treatment of the new coronavirus Covid-19, for which exceptional measures in terms of importation were taken, as per the Executive Decree No. 20-109 with details on the required documentation for the import of products mentioned in the List of Pharmaceutical Products, Medical Devices and Detection Equipment For the Fight Against Covid-19 With Exceptional Facilitating Measures

Nigeria

NAFDAC

  • NAFDAC Grants Conditional Emergency Use Approval of Medical Devices (COVID-19 Antibody and Antigen Test Kits, PPEs, etc.) Companies, 09-Apr-2020
  1. Registration by the Regulatory Authority in the Country of Manufacture
  2. Declaration of Conformity
  3. Validation/performance evaluation /Clinical Evaluation Report
  • NAFDAC has reduced the “registration to approval” time from 120 working days to 10 working days due to the COVID-19 pandemic document provides step by step guidance for the registration of alcohol based hand sanitizers made in Nigeria during Covid-19 pandemic.
  • Call for expression of interest for the COVID-19 related medicines was made; several researchers and practitioners have responded and are being guided to submit such medicines to NAFDAC for expedited review.

Morocco

Morocco Health

  • In compliance with DMP Notice No. 75 DMP/00 related to the drugs supply to local market during the Covid-19 crisis, the Directorate for Medicine and Pharmacy (DMP) informs pharmaceutical establishments that they should pay more attention to the stocks of essential molecules
  • DMP informs drugs and medical devices manufacturers and importers that measures were put in place to handle all application files, in order to avoid Covid-19 spread
  • Accelerated Review of Submitted Dossiers During Covid-19 Crisis, 16-Mar-2020: DMP informs the industry that a permanent crisis unit has been created at the DMP in order to handle emergency cases of the health crisis (Covid-19) and accelerate the review of dossiers.
  • DMP Circular No.130/DMP/00: Extended Validity for Medicines’ and Health Products’ Administrative Documents, 17-Apr-2020: DMP extended the validity of documents issued to import/export establishments until the end of the exceptional situation due to Covid-19, so that imported or exported products are not blocked by customs.

Iraq

Iraq Health

In the context of Covid-19 pandemic crisis, the Iraqi State Company for Marketing Drugs and Medical Appliances (KIMADIA) sent an announcement to the industry to share requirements to ease the importation of some products, as adopted by the Higher Committee for National Health and Safety at its 01-Apr-2020 meeting, especially the import medical devices needed during Covid-19 health crisis

Oman

Oman Health

  • In line with the different measures to control the spread of COVID-9 pandemic, the regulatory authority will not receive any letters or documents if submitted by hard copy/ All such submissions should be done through e-mail and those wich are required to be submitted through e-portal should be submitted vis e-portal only. E-mail IDs for each department were created with phone numbers in order to communicate directly with the concerned email ID:

Egypt

Egypt Health

During the Covid-19 pandemic crisis, and in order to decrease the number of physical contact with the applicants/companies’ representatives at its desks, the Egyptian Drug Authority (EDA) set up temporary measures, which include:

  • The publication of a list of emails for the submission of files, each department having its own email address.
  • List of online forms to be filled in and submitted, along with reception days and hours per procedure type.
  • This initiative depends on creation of scanned files on google drive of applicant and sending relevant link within sent files submitted by applicants on emails so as to be viewed by EDA staff and commented back with result or follow ups. This is step is a temporary one during the pandemic.

Jordan

Jordan Health

  • Following the EMA decision of 30-Mar-2020 on the issuance of freedom of sale certificates in electronic format, and signed electronically, in the context of Covid-19 crisis, the Jordan Food and Drug Administration (JFDA) informs the industry on the acceptance of such certificates as part of the medicinal products registration
  • Guidelines for Post-Marketing Reporting of Drugs Adverse Reactions In Emergency Cases Due to An Epidemic, Mar-2020 was published to set specific requirements for post-marketing reporting of drugs adverse reactions that occur in emergency cases due to an epidemic in Jordan, like during the Covid-19 pandemic.

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