Asia-Pacific Roundup: Malaysia’s MDA shortens evaluation timelines for combination products

RoundupsRoundups | 10 January 2023 |  By 

Shorter evaluation timelines and new information on the registration process highlight the fifth edition of the Malaysia Medical Device Authority’s (MDA) guideline on combination products.
 
MDA uses two terms for combination products based on their primary mode of action. If the primary mode of action is not based on pharmacological, immunological or metabolic means, the authority calls the technology a medical device-drug combination product (MDDCP). The new evaluation timelines apply to MDDCPs.
 
The new guideline calls for evaluating class B, C and D MDDCPs in 60 days, down from 100-220 days under the previous guideline. The target for class A devices remains 30 days.
 
The timeline for evaluation by the National Pharmaceutical Regulatory Agency (NPRA) has also changed. NPRA, which regulates medicines in Malaysia, aims to evaluate MDDCPs in 180 days, down from 245 days under the old guidance.
 
MDA and its collaborators also have provided new information about the MDDCP registration process. The updated guideline states that MDA may ask applicants to provide “particulars or document on the application or sample of the medical device” within 90 days. If the applicant neither provides the information nor requests more time, MDA will consider the submission to be withdrawn.
 
Other changes include the addition of an explanatory note to a section about the reporting of adverse drug reactions and incidents. The note clarifies that drug issues “may include quality defect/regulatory non-compliance related to safety.”
 
MDA Guideline
 
Pakistan seeks feedback on draft GMP guidelines designed to support consistent drug quality
 
The Drug Regulatory Authority of Pakistan (DRAP) has begun a consultation into draft guidelines on good manufacturing practices (GMPs). DRAP is creating guidelines to ensure consistent product quality, compliance with the product specification, and the minimization of risks such as contamination.
 
As it stands, Pakistan communicates its GMP requirements through the Drugs (Licensing, Registering & Advertising) Rules, 1976. DRAP has identified a need to go beyond the information contained in that law by stipulating what it expects from manufacturers of pharmaceutical and biological medicines in a new GMP guideline.
 
The draft document notes that the terms GMP and current GMP are equivalent and clarifies that the guideline excludes guidance on the safety and environmental aspects of drug production. Manufacturers are responsible for the safety and environmental aspects of their operations.
 
After establishing the scope of the guideline and the legal framework that underpins it, DRAP breaks the conditions for GMP compliance into 10 sections that cover topics including quality control, personnel, materials and documents. The sections drill down into details such as the responsibilities of the head of the production department. 
 
Elsewhere, DRAP discusses the potential consequences of noncompliance with GMPs, warning that the central licensing board can cancel drug manufacturing licenses based on inspection reports and DRAP’s registration board cancel drug registrations in response to a company’s GMP status.
 
DRAP uploaded the document on 5 January and is accepting feedback for 15 days.
 
DRAP Notice
 
Philippine FDA creates guidelines for more streamlined and digital frontline regulatory services
 
The Philippine Food and Drug Administration (FDA) has proposed changing its guidelines on frontline services considering the “new normal” that has emerged since the COVID-19 pandemic.
 
“A new landscape emerged due to the COVID-19 pandemic, and this has altered the way people live and work,” according to FDA. At the agency, the changes have resulted in more use of online platforms and virtual communication that, in the administration’s view, have made services more streamlined and digital.
 
Under the draft guidelines, FDA seeks to limit walk-in transactions to customer complaints. The submission of materials for licenses to operate, certificates of product registration, notifications and other authorization filings that can be done virtually should take place via email or online platforms.
 
FDA also lists the email addresses and online platforms that applicants can use to make different types of submissions. The schedule for receiving information related to certain types of applications is limited to particular days. 
 
FDA is accepting feedback on the draft guidelines until 20 January.
 
FDA Guidelines
 
TGA seeks feedback on down-scheduling celecoxib
 
Australia’s Therapeutic Goods Administration (TGA) is holding a consultation into whether to reschedule celecoxib, a COX-2 inhibitor, to make certain formulations pharmacy-only products.
 
Celecoxib currently is a prescription-only medicine. TGA is looking at a request to create a new, pharmacy-only entry for celecoxib for “oral use in capsules containing 200 mg or less per capsule and when in pack containing not more than 10 dosage units for the short-term treatment of period pain in adults and for the short-term treatment of acute pain in adults with muscle and joint injuries.”
 
The applicant argues that down-scheduling celecoxib would enable patients to access an alternative therapeutic agent for acute pain symptoms after talking to pharmacists, thereby facilitating access to an effective medicine, minimizing the pill burden and aiding compliance. A comparison of celecoxib to other NSAIDs such as ibuprofen found the medicines have similar safety profiles.
 
While celecoxib is associated with risks such as cardiovascular events and renal toxicity, the applicant told TGA they can be adequately addressed by limiting pack sizes to ensure short-term use, through product labeling, and via consultations with pharmacists prior to purchase. TGA has received 261 reports of adverse events for products containing celecoxib since the start of 2013.
 
If TGA allows the change, it will diverge from the policies of its regulatory peers. In a summary of international regulations, TGA noted that all the products containing celecoxib listed by regulatory agencies in the United States, New Zealand, Ireland, United Kingdom and Canada are prescription-only medicines.
 
TGA is accepting feedback until 3 February.
 
TGA Consultation
 
Pakistan threatens legal action against drug hoarders that put ‘further strain’ on supply chain
 
DRAP is threatening legal action against individuals and organizations that hoard medicines. DRAP issued the warning after seeing “false and misleading” reports on social media about the stockpiling of essential drugs because of shortages.
 
According to the regulator, “there is no reason to panic” despite “recent rumors of shortages” related to branded treatments for fever, colds and chronic ailments. While DRAP agreed that “the availability of a few brand-name drugs is strained due to global supply chain issues,” it also said that alternatives to many of the affected products are “available freely in the market.”
 
DRAP singled out insulin for discussion, noting that “temporary global shortages of insulin vials” will be resolved this month. In the meantime “injections of a specific manufacturer and its cartridges are available in ample quantities.” Insulin vials from other manufacturers are also available, DRAP said.
 
Hoarding of drugs at home, by retailers or at distributors is unethical and “puts further strain on the supply chain,” according to the DRAP notice. “Legal action will be taken against the culprits.”
 
DRAP Notice

 

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