Asia-Pacific Roundup: PMDA Outlines Project Changes Focusing on Use of Medicines in Pregnancy
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared details of changes to a system to promote the proper use of medicines for pregnant and breastfeeding women. The system went live last month to support the creation of a register and the digitization of applications.
Authorities established the Japan Institute for Drug Information in Pregnancy (JDIIP) in 2005 to collect and review the latest evidence on the effects of drugs on mothers and fetuses. Thanks to this information, the institute offers consultations to pregnant women or women wishing to become pregnant. JDIIP also uses the information to generate new evidence and to review pregnancy information on package inserts.
To strengthen the system, JDIIP designated “base” hospitals in 2017 and now collaborates with all 56 sites on consultations and research, including registry studies on COVID-19 in pregnancy and hypertension associated with the pregnancy.
Under this system, patients can submit consultation requests online, removing the barriers created by the old requirement for people to print and send paper medical questionnaires. The system will collect information on the condition of newborns and infants after birth, and safety information and medical questionnaires will circulate between the main hospitals and the National Center for Child Development and Health. .
The system will increase the volume of information available on the effects of drugs in pregnant and breastfeeding women, according to PMDA. The changes could allow “more efficient and effective epidemiological investigations” and “recruitment using the base hospital network”. PMDA expects that conclusions about drug safety enabled by the system will be reflected in package inserts, which will result in the evolution of the regulatory position on individual drugs.
Malaysia’s MDA Seeks Comments on Updating Medical Device Establishment Licenses
The Malaysian Medical Devices Authority (MDA) is holding a consultation on planned changes to the guidelines on obtaining a license to import, export or place products on the market. The draft includes an expanded glossary and new requirements for post-market responsibilities and other activities.
MDA published the first edition of its Establishment Licensing Guidelines in 2016. The document gave companies a blueprint for complying with the licensing requirements of the Medical Devices Act 2012, including information on procedures establishment license, obligations of licensees, process for notifying changes. and renewals.
The draft second version of the text is largely identical to the original. The most significant change is to the glossary, where MDA seeks to add and define the new terms authority, distributor, establishment, licensee, place in the market, retailer and manufacturer. Definitions of existing terms are unchanged.
MDA is also proposing some changes to the general requirements, such as adding a line stating that an importer and distributor who is also an authorized representative must obtain a letter of authorization from the manufacturer who has appointed them as an authorized representative.
The draft also includes a new sub-section on post-market responsibilities which requires establishments to comply with the Medical Devices (Duties and Obligations of Establishments) Regulations 2019; be responsible for all medical devices placed on the market in accordance with the authorization of the manufacturer or his authorized representative; and continuously ensure the safety and performance of their products throughout the supply chain.
MDA is also looking to add a statement that multiple authorized representatives are authorized for the same medical device and to remove a line about the need to obtain establishment licenses for the manufacturer and authorized representative.
MDA is accepting comments on the draft until June 24.
Malaysian NPRA adopts updated position on changes to manufacturing facilities
The Malaysian National Drug Regulatory Agency (NPRA) has updated its position on Type III and IV modifications to manufacturing facilities. The update affects changes to foreign manufacturing facilities and factories that manufacture sterile products.
From June 15, Malaysia will have a detailed description of Type III changes to the location of facilities outside the country. The new text provides a more detailed breakdown of when a company can make a Type III variation.
Type III changes cover relocation of drug production to another site operated by the manufacturer or its subsidiary, as well as transfers to contract manufacturing organizations and local facilities to overseas facilities. The last two types of relocation only apply to certain product categories, including new drugs, biologics, and generics containing scheduled and unscheduled poisons.
ONPR simplified its description of Type IV modifications and aligned the text with the new section on Type III modifications. The new text states that Type IV amendments cover the relocation of manufacturing of sterile products within Malaysia, between overseas sites and between facilities inside and outside the country. Transfers can be internal or to a contract manufacturing organization.
Philippine FDA plans outright ban on mercury medical devices amid ‘ramping’ online sales
The Philippines Food and Drug Administration (FDA) is planning a total ban on mercury-containing medical devices after previous efforts failed to crack down on the “crazy sale” of such products on digital platforms.
In recent years, the Philippines has taken a series of actions in accordance with its obligations as a signatory to the 2013 global mercury treaty. However, previous actions lacked provisions to tackle the online sale of thermometers and other medical devices containing mercury. In the absence of such provisions, the sale of mercury-containing devices has been “widespread” on social media and online retail sites.
The FDA responded to continued sales of the devices with a memorandum seeking to “totally ban” the production, trade, and promotion of thermometers, sphygmomanometers, dental amalgam capsules, and mercury-added liquid mercury for any purpose. dental restoration. The circular lists a series of device-related activities that are “strictly prohibited”.
The circular will come into effect later this month.
After withdrawing drug tracking proposal, NPPA reissues unchanged project terms
India’s National Pharmaceutical Pricing Authority (NPPA) has reiterated its request for expressions of interest for a project to track certain drugs through the national supply chain.
The NPPA withdrew the original request last week after failing to find bidders who met its original terms. The price watchdog planned to publish a new proposal with revised terms “soon”. Three days later, the NPPA posted a new tender on India’s procurement portal.
The new proposal extends the submission deadline from May 2 to June 23 and adds Rs 3,000,000 ($38,500) as the bid value. However, the solicitation document is the same as the original Request for Expression of Interest. The scope of work, which covers the collection, analysis and presentation of drug supply data, is unchanged, as are the terms and conditions and eligibility criteria.
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