Pakistan’s DRAP encourages users to update pharmacovigilance app after recent revisions

The Drug Regulatory Authority of Pakistan (DRAP) has asked users of its Med Safety App to update the software to take advantage of new features and bug fixes implemented by the developer. DRAP published a notice about a “significant update” implemented by its counterpart in the UK. DRAP told users the MHRA update allows its National Pharmacovigilance Centre “to ask specific questions relating to a patient’s report based on the information provided.”

Important Notice to Pharmaceutical / Biological Manufacturers and Importers

DRAP has deployed an online application management system namely, Pakistan Integrated Regulatory Information Management System (PIRIMS) for processing of regulatory information related to licensing, registration and inspections of pharmaceutical and biological drugs. All the Registration Holders of pharmaceutical and biological drug products are directed to update the finished product specifications and validated testing procedures i.e. Pharmacopoeial or in case of non-availability in any pharmacopeia, Innovator / Manufacturer’s Specification, in the corresponding product profile / details in the PIRIMS at http://pirims.dra.gov.pk. The portal to perform the above-said activity will remain accessible for thirty days after publication of this notice and afterwards, no request shall be entertained.

Malaysia’s NPRA creates declaration of worldwide registration status for generic medicines

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has created a template for declaring the worldwide registration status of generic medicines in its Quest online submission system. The template asks users to provide information including the name of the product, its application status, and the application type and registration number in the registered country. If the application type is the decentralized procedure, NPRA wants the applicant to include the reference member state on the form. The template supports the provision of information about multiple products. NPRA has designed the template for use with all new applications for prescription generic medicines. The creation of the template follows NPRA’s publication of a guide to uploading bioequivalence study reports to the Quest 3+ online portal and its updating of the guidance notes for active pharmaceutical ingredient information for product registration.

Declaration of Worldwide Registration Status for Generic Medicines in QUEST System

All new applications for Generic Medicines (Prescription-Full) shall declare its worldwide registration status (WWRS) using this specific template [effective date: 13/3/2023]. The link is below for the template or it can be obtained from NPRA website [Industry-Generic Medicines-Downloadable Forms]: Template-for-Declaration-of-Worldwide-Registration-Status-WWRS-E15

Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application

Malaysia drug regulatory authority, NPRA published Approved Clinical Trial Import License & Clinical Trial Exemption (CTX) Application.

Philippine FDA shares guidelines on regulatory reliance for the conduct of clinical trials

The Philippine Food and Drug Administration (FDA) has posted guidelines about relying on the decisions of other regulatory agencies to facilitate the evaluation of clinical trial applications. The document sets out the rules for sponsors, contract research organizations, investigators and research ethics committees that are involved in all phases of multi-region clinical trials. Under the guidance, drug developers can receive clearance to run some clinical trials under the abridged regulatory pathway. The pathway enables FDA to solely or partially base its decision on the assessment of a reference drug regulatory agency (RDRAs) such as the European Medicines Agency and US Food and Drug Administration. The Philippine regulatory agency has designated 14 of its peers as RDRAs.

Fourth amendment to regulation of the head of drug control agency and food concerning criteria and procedure of drug registration

Several provisions regarding the types of changes, requirements, and completeness of variation registration documents in Appendix XVI to the Regulation of the Head of the Drug and Food Control Agency Number 24 of 2017 concerning Criteria and Procedures for Drug Registration amended so that it becomes as stated in the Appendix which is an integral part of this Agency Regulations.

Precautions for Handling of Sustained-Release preparations

PMDA published Precautions for Handling of Sustained-Release preparations. Properties of sustained-release preparations and risks when crushed, Prevention of administering crushed tablets using a prescription ordering system are published.

Import and supply of an unregistered therapeutic product for patients’ use

This guidance outlines the special access route under regulation 5(1)(b)(i) and 51 of the Health Products (Therapeutic Products) Regulations for the import of an unregistered therapeutic product, as well as its subsequent supply under regulation 58(1)(f) and (g) of the Regulations. These regulations serve to facilitate access to life-saving therapies where there is an unmet medical need, such as in situations where treatment option is absent, and the patient’s health will be clinically compromised without treatment with the unregistered therapeutic product.

Application for consignment approval of an unregistered therapeutic product for patients’ use

Singapore drug regulatory authority, HSA published signed request for named-patient application type. This should be completed by the requesting doctor or dentist).

Signed request for buffer stock application type

HAS published application for consignment approval of an unregistered therapeutic product for patients’ use. All applicants must comply with the health products act (hpa) and its regulations. This is signed request for buffer stock application type (To be completed by the requesting doctor, dentist or pharmacist).

EMA Highlights Trial Innovation, Real-World Data Advances

The European Medicines Agency (EMA) reported “remarkable” progress despite the pandemic in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation including advances in clinical trials and a new real-world data (RWD) network. The 65-page report, which looks at progress made from March 2020 to December 2022, notes the launch of the EU’s Clinical Trials Information System, which went live as a searchable public website in January 2022. The agency also launched the Accelerating Clinical Trials initiative to help develop the EU as a center for innovative clinical research.

Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

EMA published Revised implementing rules to the Fee Regulation as of 1 April 2023. This includes marketing authorization, variation, annual fee, inspection fee.

Guideline on computerized systems and electronic data in clinical trials

The European Medicines Agency (EMA) has offered recommendations for electronic data collection in clinical trials in a new final guidance. This guideline replaces the ‘Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials’ (EMA/INS/GCP/454280/2010).

Explanatory note on general fees payable to the European Medicines Agency

This explanatory note is meant as a guidance note only. Changes introduced in this version: Increase in the level of fees other than administrative fees to adjust for an inflation rate of +10.4% and rounding off to the nearest EUR 100, Increase in the level of all administrative fees to adjust for an inflation rate of +10.4% and rounding off to the nearest EUR 10.

EMA Q&A addresses submission of data elements for raw data pilot

The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical trial data for marketing authorization applications (MAAs) and post-authorization applications. EMA issued an updated guidance on the pilot in October. The purpose of the pilot is to “investigate the benefits of having access to raw data from regulatory submissions to support the scientific assessment of medicinal products and to identify the associated operational, resource and technological needs.”

Regulatory, industry panels address EU GMP Annex 1 implementation

Pharmaceutical manufacturers in the EU may have to approach the manufacturing of sterile drugs a little differently under the EU’s Annex 1 covering good manufacturing practices (GMPs), which goes into effect soon. For example, regulators may be asking to see whether firms have a documented contamination control strategy (CCS) and may require firms to conduct pre- and post-sterilization integrity testing (PUPSIT) on filters used in sterile drug manufacturing. In the meantime, regulators from the US Food and Drug Administration (FDA) said that while they will not be enforcing Annex 1, inspectors will be looking into similar areas as their counterparts in the EU.

FDA Issues Guidance on ISO Data Standards for Medicinal Products

As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued a final guidance on the use of five International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards.

ICH Finalizes S12 Guideline Covering Gene Therapy Products

The International Council for Harmonization (ICH) has finalized a new guideline covering nonclinical considerations for gene therapies, setting the stage for individual ICH member nations to accept and release their own versions of the guideline.

FDA Guidance Advises RCTs for Oncology Drugs Seeking Accelerated Approval

Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most cases, the FDA advises in new draft guidance issued last week.

Guidance details review process for pediatric research not approvable by an IRB

The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process for referring research involving children in cases where such research would not normally be approvable by an IRB. In such cases, an IRB may refer the study to FDA or the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP). Conducting pediatric clinical trials is a sensitive matter, and researchers and regulators must be even more cautious when they are involved in clinical trials or other regulated human subjects research. Typically, if a trial puts a patient at any significant risk, an IRB must oversee the study to ensure the interests of patients are addressed.

FDA Publishes Final Guidance on Meaning of ‘Suspect’ and ‘Illegitimate’in DSCSA

The FDA clarified the agency’s interpretations of what is meant by “suspect” and “illegitimate” products in the Drug Supply Chain Security Act (DSCSA) in a final guidance.

FDA Shares Latest Thinking on Electronic Systems, Signatures and Records in Trials

The FDA offers recommendations for using electronic systems, records and signatures in clinical trials, including advice on validation, in a draft guidance

New FDORA Provision Allows FDA to Conduct Some Inspections Based on Records Review

In a potentially “game-changing” legislative move, the Food and Drug Omnibus Reform Act of 2022 (FDORA) has given the FDA the option to rely on review of records and other information collected from a manufacturer in lieu of some types of on-site inspections.

FDA Offers Guidance on Potency Assays for Antibodies That Target Viral Proteins

A new draft guidance from the FDA offers drug sponsors recommendations for developing potency assays for every stage of the lifecycle of monoclonal antibodies (mAbs) that directly target viral proteins.

FDA encourages RCTs in accelerated approval guidance for oncology

The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs) – rather than single-arm studies — the “preferred approach” to support accelerated approval. Sponsors can conduct a single RCT to support accelerated approval and verify clinical benefit or run two trials, one that supports accelerated approval through the use of an early endpoint and one confirmatory trial that is powered to assess a longer-term clinical endpoint, according to the draft guidance.

FDA outlines plan for digital health technologies for clinical trials

The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digital health products generally, there is still concern about whether such products are accurate and reliable enough to gather data for the drug development process

FDA issues guidance on submission of pharmacogenomic data

The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory submissions for investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs). The guidance also provides recommendations to sponsors on the format and level of detail for reporting pharmacogenomic data submissions, which will vary based on how the genomic biomarkers are used and the potential risks. When finalized, this new guidance will replace final guidance for industry that FDA published in 2005.

Industry requests more information from FDA on dosage and administration labeling

While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of prescription drug labeling is significantly larger than an earlier guidance issued in 2010, industry stakeholders said they wanted more information from the agency on how labeling of specific cases should be handled. FDA’s draft guidance on improving development of the dosage and administration section of drug labeling is written to inform industry on required and recommended information that is “particularly critical to the safe and effective use of the drug,” such as the dosage range, starting or loading dose, dosage, titration schedule, maximum recommended dosage and duration, effectiveness, and concomitant therapy information, the agency said.

FDA issues guidance on developing long-acting local anesthetics

The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect that can last for days. The guidance, published is part of a larger effort to reduce the use of opioid analgesic drugs, according to FDA. “Although different local anesthetic drug products have different pharmacokinetic (PK) profiles, in general their effects last a few hours. However, the increasing interest in reducing or eliminating the use of opioid analgesic drug products is leading to development of dosage forms of local anesthetic drug products that prolong the duration of action of the drug product to a period of days rather than hours,” the agency wrote.

FDA Offers Advice on Macular Degeneration Drug Trials

The 8-page draft which includes recommendations on trial eligibility criteria, efficacy endpoints and trial design considerations recommends that sponsors consider parallel-group, double-masked trials randomized by patient that aim to show the investigational drug group’s superiority over the control group. Sponsors can also consider an alternative trial approach that uses the same design but shows the investigational drug’s noninferiority to either ranibizumab injection given intravitreally every four weeks, or to aflibercept given intravitreally either every four weeks or eight weeks (after three monthly injections), the agency says.