The Philippines Food and Drug Administration (FDA) is seeking comments on draft guidelines to streamline the process for changing labels on pharmaceutical products covered by maximum retail prices (MRPs).
In recent years, the Philippines has established and expanded a list of drugs covered by MRPs to ensure access to affordable and quality pharmaceuticals. The government added 34 drug molecules and 71 additional drug formulations to the list of hundreds of drugs already covered by MRPs late last year.
The FDA has now released a draft document that defines “a streamlined and streamlined request process for changing drug product labeling materials under MRP.” The FDA believes the project will help reduce the regulatory burden of obtaining approval for using or updating MRP statements on product labels.
The guidelines require products to carry the two-line statement “under drug price regulation; sale price not to be exceeded [price]on their primary and secondary packaging, including each blister pack and any small containers. Manufacturers should write the statement in capital letters using either white or black text on a red background, or red text on a white background. The draft presents mock-ups of what the statement might look like.
Whether manufacturers should follow the FDA post-approval changes circular for products already on the market. FDA requires manufacturers to submit minor change notifications that include supporting documentation such as a notarized application form, a signed copy of the integrated application form, and a statement signed by the regulatory office official that the changes are limited. to the proposed MRP change.
The FDA, which is accepting comments until May 6, is proposing to give manufacturers a “one-year exhaustion period for old manufacturing-level labeling materials” from the date the FDA becomes effective. the circular.
DRAP seeks feedback on promoting pharmacovigilance activities in public health programs
The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidelines on promoting pharmacovigilance activities in public health programmes. DRAP created the project to improve the safety of therapeutic products used in public health programs and ensure the early detection of problems.
Pakistan runs public health programs to prevent and eradicate diseases such as tuberculosis, malaria and HIV. DRAP views the documentation and reporting of adverse events after administration of drugs and vaccines used exclusively by programs as essential to its pharmacovigilance initiative.
According to the DRAP, program managers and staff have insufficient training in pharmacovigilance, mistakenly assume that drugs are universally safe, and mistakenly believe that reports of adverse events will negatively impact programs.
To improve the situation, the DRAP wants to install pharmacovigilance coordinators who will integrate public health programs at the national and provincial levels with the National Center for Pharmacovigilance. The DRAP also wants the coordinator at the federal level to maintain a system of international standards.
The draft guidelines also deal with procedures. The DRAP wants public health programs to have defined procedures that describe the practical details of the expected flow of information and that are harmonized with the guidelines. At a minimum, procedures should address topics such as what constitutes a reportable adverse event and who is expected to report suspected issues.
DRAP, which published the draft on April 23, is accepting comments on the 55-page draft for 15 days.
Malaysia’s MDA releases guidelines on classification of rehabilitation medical devices
Malaysia’s Medical Device Authority (MDA) has created guidelines 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 for rehabilitation, physiotherapy and speech-language pathology products for consultation in February. While finalizing the text, MDA made multiple changes, both to the form and content of the list of products classified as medical devices and to other sections such as the glossary and the overview of the general requirements of classification.
The draft list included both products that are and are not classified as medical devices. MDA differentiated the two product types by including a column titled “medical device” that put “yes” or “no” next to each product. The regulator removed all products that are not classified as medical devices from its final list, along with the now redundant column indicating whether a product is a medical device. MDA has also added “exercise band and tube” for rehabilitation and physiotherapy to the list of devices.
Elsewhere, MDA removed the term “active medical device for therapeutic purposes” from the glossary. The draft defined the term as a device “intended by the manufacturer to be used on a person, alone or in combination with another medical device, to support, modify, replace or restore biological functions or structures for the purpose of treating or relieve an illness, injury or disability.
MDA removed a similar statement from a section on general requirements for classification of medical devices. The agency also removed rows on software and interventions that are not considered medical devices, resulting in a shorter discussion of general requirements.
Japanese PMDA Releases Translation of Changes to Basic Principles of Global Clinical Trials
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released an English version of the changes it made to its Guiding Principles on Global Clinical Trials late last year. The PMDA has made the necessary changes to reflect new guidelines on the long-term safety evaluation of drugs in Japanese subjects.
The changes affect a question about how many Japanese patients should be included in long-term safety evaluations of a drug intended for the long-term treatment of a non-fatal disease if a global clinical trial found that the data were consistent between subjects inside and outside the country. In its initial response, the 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 revamped its answer in the latest version of the Q&A. The new answer is shorter and clearer on how many Japanese subjects to track 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, if there is difficulty in recruiting subjects, a safety assessment using trial data not satisfying such a 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, exploratory stage of drug development and data from multiple studies have shown no marked differences in terms of security between the Japanese and the non”. -Japanese subgroups. Drugs approved in Japan for other similar indications can rely on post-marketing data to reduce the need for long-term follow-up in local patients.
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