Asia-Pacific Roundup: PMDA outlines changes to project focused on medicine use in pregnancy
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared details of changes to a system for promoting the proper use of drugs for pregnant and breastfeeding women. The system went live last month to support the creation of a registry and the digitization of applications.Officials created the Japan Drug Information Institute in Pregnancy (JDIIP) in 2005 to collect and review the latest evidence on the effects of medicines on mothers and fetuses. Using the insights, the institute provides consultations for women who are pregnant or wish to become pregnant. JDIIP also uses the information to generate new evidence and to review pregnancy-related information on package inserts.
To strengthen the system, JDIIP designated “core” hospitals in 2017 and now collaborates with the 56 sites on consultations and research, including registry studies on COVID-19 during pregnancy and pregnancy-associated hypertension.
Under the system, patients can file consultation applications online, thereby removing the barriers created by the old requirement for people to print and mail paper medical questionnaires. The system will collect information on the status of neonates and infants after birth, and safety information and medical questionnaire inputs will flow between the core hospitals and the National Center for Child and Health Development.
The system will increase the volume of information that is available on the effects of medicines in pregnant and breastfeeding women, according to PMDA. The changes could enable “more efficient and effective epidemiological surveys” and “recruitment using the network of core hospitals.” PMDA expects the findings on the safety of medicines enabled by the system to be reflected in package inserts, driving the evolution of the regulatory position on individual medicines.
PMDA Notice
Malaysia’s MDA seeks feedback on update to medical device establishment licenses
Malaysia’s Medical Device Authority (MDA) is holding a consultation about planned changes to guidance on obtaining a license to import, export or place products on the market. The draft features an expanded glossary and new requirements for postmarket responsibilities and other activities.
MDA released the first edition of its guidance on licensing for establishment in 2016. The document gave companies a blueprint for complying with the licensing requirements of the Medical Device Act 2012, including information on establishment licensing procedures, the obligations of licensees, the change notification process and renewals.
The draft second version of the text is largely the same as the original. The most extensive change is to the a glossary, where MDA seeks to to add and define the new terms authority, distributor, establishment, licensee, place in the market, retailer and manufacturer. The definitions of the existing terms are unchanged.
MDA also proposes some tweaks to the general requirements, for example by adding a line that states an importer and distributor that is also an authorized representative must get a letter of authorization from the manufacturer that appointed them as an authorized representative.
The draft also includes a new subsection on postmarket responsibilities that requires establishments to comply with the Medical Devices (Duties and Obligations of Establishments) Regulations 2019; be responsible for all medical devices put on the market in accordance with the authorization from the manufacturer or authorized representative; and continuously ensure the safety and performance of their products throughout the supply chain.
MDA also seeks to to add a statement that multiple authorized representatives are allowed for the same medical device, and remove a line about needing to obtain establishment licenses for the manufacturer and authorized representative.
MDA is accepting feedback on the draft until 24 June.
Draft Guidance
Malaysia’s NPRA adopts updated position on changes to manufacturing facilities
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated its position on Type III and IV changes to manufacturing facilities. The update affects changes to foreign manufacturing facilities and plants that make sterile products.
As of 15 June, Malaysia will have an expanded description of Type III changes to the location of facilities outside of the country. The new text provides a more detailed breakdown of the situations in which a company may make a Type III change.
Type III changes cover the relocation of medicine production to another site run by the manufacturer or its subsidiary, as well as transfers to contract manufacturing organizations and from local to overseas facilities. The latter two relocation types are only applicable to certain product categories, including new drug products, biologics and generics containing scheduled and non-scheduled poisons.
NPRA has simplified its description of Type IV changes and brought the text in line with the new section on Type III changes. The new text states Type IV changes cover the relocation of the manufacture of sterile products within Malaysia, between foreign sites and between facilities located inside and outside of the country. The transfers can be internal or to a contract manufacturing organization.
NPRA Update
Philippine FDA plans total ban on mercury medical devices amid ‘rampant’ online sales
The Philippine Food and Drug Administration (FDA) is planning a total ban on mercury-added medical devices after earlier efforts failed to quell the “rampant sale” of such products on digital platforms.
In recent years, the Philippines has taken a series of actions in line with its obligations as a signatory to the 2013 global treaty on mercury. However, the earlier actions lacked provisions to tackle the online sale of thermometers and other medical devices that contain mercury. In the absence of such provisions, the sale of mercury-added devices has been “widespread” on social media and online retail sites.
FDA has responded to the continued sales of the devices with a circular that aims to “totally ban” the production, trade and promotion of mercury-added thermometers, sphygmomanometers, dental amalgam capsules and liquid mercury for use in dental restorative purposes. The circular lists a range of activities related to the devices that are “strictly prohibited.”
The circular will take effect later this month.
FDA Notice
After pulling drug tracking proposal, NPPA re-issues unchanged terms for the project
India’s National Pharmaceutical Pricing Authority (NPPA) has reissued its request for expressions of interest in a project to track certain medicines throughout the national supply chain.
NPPA withdrew the original request last week after failing to find bidders who met its original terms. The price watchdog planned to issue a new proposal with revised terms “shortly.” Three days later, NPPA published a new tender on India’s procurement portal.
The new proposal pushes back the deadline for submissions from 2 May to 23 June and adds Rs 3,000,000 ($38,500) as the tender value. However, the tender document is the same as the original request for expressions of interest. The scope of work, which covers the collection, analysis and presentation of data on medicine supply, is unchanged, as are the terms and conditions and eligibility criteria.
Procurement Listing
