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Posted 26 April 2022 | By Nick Paul Taylor 

Asia-Pacific Roundup: Philippine FDA seeks input on easing maximum retail price labeling process

2989 The Philippine Food and Drug Administration (FDA) is seeking feedback on draft guidelines intended to streamline the process for changing labels on drug products covered by maximum retail prices (MRPs).
 
In recent years, the Philippines has established and expanded a list of medicines that are covered by MRPs to ensure access to affordable, quality drug products. The government added a further 34 drug molecules and 71 drug formulas to the list of hundreds of medicines already covered by MRPs late last year.
 
The FDA now has published a draft document that sets out “a streamlined and rational application process for the change of labeling materials of drug products under MRP.” FDA believes the draft will help  reduce the regulatory burden of obtaining approval for the use or update of MRP statements on product labels.
 
The guidelines require products to carry the two-line statement “under drug price regulation; retail price not to exceed [price]” on their primary and secondary packaging, including each blister pack and any small containers. Manufacturers need to write the statement in all caps using either white or black text on a red background, or red text on a white background. The draft features mockups of how the statement could look.
 
If manufacturers need to follow the FDA circular on post-approval changes for products already on the market. FDA is asking manufacturers to submit minor variation notifications that include supporting documents such as a notarized application form, a signed copy of the integrated application form and a signed declaration by the head of the regulatory office that the changes are limited to the proposed MRP variation.
 
FDA, which is accepting feedback until 6 May, is proposing to give manufacturers a “one-year exhaustion period of old labeling materials at the manufacturing level” from when the circular takes effect.
 
Draft Guidelines
 
DRAP seeks feedback on promoting pharmacovigilance activities in public health programs
 
Pakistan’s Drug Regulatory Authority of Pakistan (DRAP) has released draft guidelines on the promotion of pharmacovigilance activities in public health programs. DRAP created the draft to improve the safety of therapeutics used in public health programs and ensure the timely detection of problems.
 
Pakistan runs public health programs to prevent and eradicate diseases such as tuberculosis, malaria and HIV. DRAP sees the documentation and reporting of adverse events after the administration of medicines and vaccines used exclusively by the programs as essential to its pharmacovigilance initiative.
 
 
According to DRAP, program managers and staff have insufficient pharmacovigilance training, falsely assume that the medicines are universally safe and wrongly think adverse event reports will have negative impacts on the programs.
 
To improve the situation, DRAP wants to install pharmacovigilance coordinators who  will integrate public health programs at national and provincial levels with the National Pharmacovigilance Centre. DRAP also wants the federal level coordinator to maintain an international standard system.
 
The draft guidelines also address procedures. DRAP wants public health programs to have defined procedures that describe the practical details of the intended information flow and are harmonized with the guidelines. At a minimum, the procedures need to address subjects such as what constitutes a reportable adverse reaction and who is expected to report suspected problems.
 
DRAP, which published the draft on 23 April, is accepting feedback on the 55-page draft for 15 days.
 
Draft Guidelines
 
Malaysia’s MDA publishes guidance on classification of rehabilitation medical devices
 
Malaysia’s Medical Device Authority (MDA) has created guidance to help manufacturers and authorized representatives classify rehabilitation, physiotherapy and speech therapy products. The centerpiece of the document is a list of products that MDA classifies as medical devices.
 
MDA released a draft guidance document on rehabilitation, physiotherapy and speech therapy products for consultation in February. In finalizing the text, MDA has made multiple changes, both to the form and content of the list of products classed as medical devices and to other sections such as the glossary and overview of the general classification requirements.
 
The draft list included both products that are and are not classed as medical devices. MDA differentiated between the two types of products by including a column titled “medical device” that put “yes” or “no” next to each product. The regulator has removed all the products that are not classed as medical devices from its final list, as well as the now-redundant column indicating whether a product is a medical device. MDA also added “exercise band and tubing” for rehabilitation and physical therapy to the list of devices.
 
Elsewhere, MDA has removed the term “active medical device for therapy” from the glossary. The draft defined the term as a device “that is intended by the manufacturer to be used on a person, either alone or in combination with another medical device, to support, modify, replace, or restore biological functions or structures for the purpose of treating or alleviating an illness, injury, or handicap.”
 
MDA removed a similar statement from a section on the general requirements for the classification of medical devices. The agency also removed lines about software and interventions that are not considered to be medical devices, resulting in a shorter discussion of the general requirements.
 
MDA Guidance
 
Japan’s PMDA releases translation of changes to basic principles on global clinical trials
 
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published an English-language version of the amendments it made to its basic principles on global clinical trials late last year. PMDA made the changes to reflect new guidance on the evaluation of the long-term safety of drugs in Japanese subjects.
 
The changes affect a question about how many Japanese patients need to be included in evaluations of the long-term safety of a drug intended for long-term treatment of a non-fatal disease if a global clinical trial found the data were consistent across subjects inside and outside of the country. In its original response, PMDA cited the ICH E1 guideline and said “it is difficult to specify the number of Japanese subjects required in such a case because the sample size for a clinical trial differs for each drug.”
 
PMDA has completely revised its response in the latest version of the Q&A. The new response is shorter and clearer about how many Japanese subjects need to be followed and for how long.
 
“In general, safety data should be collected from approximately 100 or more Japanese subjects who have been treated for 1 year. However, in case of difficulty in enrolling subjects, a safety evaluation using data from trials not satisfying such number of subjects may still be possible in some situations,” PMDA wrote.
 
Examples of when fewer Japanese patients may be acceptable include when the country has been “continuously involved in global clinical trials from an early and exploratory stage of drug developments and the data from multiple studies has not demonstrated any marked difference in safety between the Japanese and non-Japanese subgroups.” Drugs approved in Japan for other similar indications can rely on post-market data to reduce the need for long-term follow up in local patients.
 
PMDA Amendment

 

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